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Trial registered on ANZCTR

Registration number

ACTRN12626001120369

Ethics application status

Approved

Date submitted

17/07/2026

Date registered

9/09/2026

Date last updated

9/09/2026

Date data sharing statement initially provided

9/09/2026

Type of registration

Retrospectively registered

Titles & IDs

Public title

A pilot study evaluating the effects of deep brain stimulation (DBS) on sleep and pulmonary function in Parkinson's Disease (PEDS-PD study)

Scientific title

A pilot study evaluating the effects of deep brain stimulation (DBS) on sleep and pulmonary function in Parkinson's Disease (PEDS-PD study).

Additional trial identifiers [1]

Nil

Universal Trial Number (UTN)

Trial acronym

PEDS-PD study

Related trial records

Health condition

Health condition(s) studied:

Sleep dysfunction

Pulmonary dysfunction

Parkinson's disease

Condition category

Condition code

Neurological

Parkinson's disease

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

This is a Deep Brain Stimulation (DBS) interventional study comparing three DBS groups (Subthalamic nucleus (STN), Caudal Zone incerta (CZi), Globus pallidus interna (GPi), each with 10 subjects, during ON and OFF stimulation (n=30). A medically managed Parkinson’s disease (PD) group (n=40) and a further 20 control subjects will be included. The 3 DBS groups will have sleep and pulmonary interventions during their ON and OFF phase. Each patient will act as their own control when they are evaluated OFF DBS. The medically managed breathless patients will be evaluated with the pulmonary interventions only.

There is no surgical intervention as part of this clinical trial. Patients with existing DBS devices, in situ for at least 1 year in duration, who fulfil the inclusion and exclusion criteria and consent to participation will undergo sleep and pulmonary interventions. The parameters of the DBS settings are not standardised in the patients. These are based on individual responses to therapy and will be predetermined and stable by the treating neurologist before they take part in this study.

The sleep intervention is an overnight polysomnography testing which requires attachment of electrodes to head and body to monitor sleep cycle state (rapid eye movement sleep, stages of sleep, periodic limb movements of sleep), and vital parameters (heart rate, rhythm and oxygen saturation concentration), while the patient sleeps in the controlled environment of the sleep laboratory. This intervention will be performed by a qualified sleep scientist, with the Principal Investigator (PI), a neurologist, present.. The patient would arrive at 8pm for initiation of this study. The sleep study itself will run from 10pm to 6am (the following morning). Once the overnight sleep study is complete, the equipment will be removed from the patient. The patient will then undertake one computer based assessment where their wakefulness will be measured by evaluating the reaction time to a computer generated stimulus. This test will take a further 10 minutes to complete. The sleep intervention will be performed by the patient with the DBS ON with their routine settings running, where no adjustments will be made to the stimulation parameters. The individual settings of patients will vary from patient to patient and is determined by their treating neurologist. Where possible, the overnight polysomnography will also be undertaken in the same patient on a separate visit within 6 months duration from the first, with the DBS turned OFF. The patient will arrive for the sleep study at 8pm and have their DBS device switched OFF by the PI. The sleep study will commence at 10pm and run until 6am the following morning. The wakefulness testing will be completed. And the patient's DBS will be turned back ON by 8am prior to them leaving the laboratory.

Similarly the pulmonary testing will be done in PD patients with existing DBS in situ. The patient will attend the laboratory at their designated time for their individual tests. These tests include a lung function testing which is where the patient will be asked to breathing into a tube which measures their lung capacity/parameters including forced vital capacity, total lung volume etc. This will take 40 minutes to complete. This will be followed by a cardiopulmonary testing which entails the patient having electrodes placed to measure their heart rate, and wearing a mask device to measure oxygen concentration. They will be asked to exercise on a bike in an incremental pattern over 15 minutes to determine the response of their cardiopulmonary system to incremental exercise. These are standardised tests performed by trained respiratory scientists in a controlled, safe environment. The PI will be present to ensure comfort and safety for all study participants. When testing the patients in the DBS OFF state, the patient will be asked to attend the laboratory two hours before their test so the PI can switch OFF the DBS device. The DBS will be turned back on by PI once the tests are completed.

The DBS patients will also be asked to attend the laboratory on a separate occasion, within 6 months from the first tests, to undertake the Control of Ventilation (COV) study. This test involves the subject being seated and application of saturation probe for monitoring as well as a breathing apparatus with a tight seal round the mouth which measures carbon dioxide and oxygen concentrations. The patient is asked to breathe normally while the investigators adjust the concentration of oxygen and carbon dioxide the patient inhales while measuring their saturation and breathing index. This information is recorded on a digital graph format to interpret. The test takes 30 - 40 minutes to complete with the subject being attached to the apparatus for approximately 15 minutes in total. The remainder of the time is spent setting up the test and apparatus by the scientists.

For the medical managed PD patients, the pulmonary tests will only be performed in the ON state which will be defined as 2 hours post last levodopa ingestion. The will undergo the pulmonary testing as described above on two separate occasions too.

For all the assessments in the DBS patients, we will switch off the DBS 2 hours before the test is due to start.

ON will be defined as two hours post medication duration in the medically managed PD patients. The ON and OFF states will be recorded by using Unified Parkinson's Disease Rating Scale (UPDRS) Motor Part 3. For those patients with DBS in situ, the ON is defined as the DBS functioning normally in the ON state. OFF state in the DBS patients will be considered when the DBS device is turned off by the PI.

The parameters of DBS will not be identical for each individual patient. These will vary depending on the therapeutic response for each individual patient, which is considered gold standard practice as no two patients will ever have the same DBS settings due to the variation in clinical symptoms and response to treatment. We will attempt to make reference to this in the analysis and discussion section as a potential confounder . Please note that addressing the relationship of DBS parameters with outcome measures is not the primary aim of this study. Instead, we are attempting to see if there is any correlation with site of DBS insertion (i.e Subthalamic nucleus, Caudal Zona incerta and Globus pallidis interna) and outcome measures.

The washout period will be a minimum of 1 month between treatments.

Approximate range for DBS parameters are:
Amplitude 1.5 - 6.0 milliamps
Pulse width 20 - 60 microseconds
Frequency 130 - 160 hertz

Intervention code [1]

Treatment: Devices

Description of the comparator or control

The OFF stimulation group will be considered as controls for the DBS outcomes, thus each patient will act as their own control during the OFF phase.

Within the Respiratory unit, normalised values are well-established for the two pulmonary tests; General respiratory function test (GRFT) and Incremental cardiopulmonary exercise test (ICPET). However minimal data exists for the Control of Ventilation (COV) study. Thus a further 20 healthy volunteers will undertake a COV study. The breathless medically managed PD participants will be compared to normalised data available for GRFT and ICPET and the COV results from the control group. The control group will consist of 20 healthy non-smoking volunteers, with no pre-existing respiratory or cardiac diagnosis/dysfunction (as per the exclusion criteria). They will be of similar age to the study subjects (age 50-80) and consist of half men and women.

Comparator intervention delivery:
For all groups:
1 x1 hour for recruitment consultation for answering any question and providing signed consent.

Sleep testing:
1 x 12-14 hours for DBS ON state sleep study and morning wakefulness testing at local hospital
1 x 12 -14 hours for DBS OFF state sleep study and morning wakefulness testing at local hospital

Pulmonary testing:
1 x 3 hours for DBS ON state for general respiratory function testing and cardiopulmonary testing
1 x 2 hours for DBS ON state for control of ventilation testing and questionnaires
1x 3 hours for DBS OFF state general respiratory function testing and cardiopulmonary testing
1 x 2 hours DBS OFF state control of ventilation testing and questionnaires

Pulmonary testing for medically managed PD patients:
1x 3 hours for medically managed PD patients for general respiratory function testing and cardiopulmonary testing
1 x 2 hours for control of ventilation testing and questionnaires

Control healthy subjects for COV testing only:
1 x 1 hour for control of ventilation testing in health controls

All interventions will be performed by the sleep and pulmonary scientists face to face with the presence of the PI who is a medically qualified Neurologist with subspecialty training in movement disorders.

The pulmonary procedures including the overnight polysomnography, wakefulness testing will be performed by sleep scientists. The pulmonary testing including general lung function, incremental cardiopulmonary testing and control and ventilation testing will be performed by pulmonary scientists. The questionnaires including Unified Parkinson Disease Rating Scale, quality of life measure, anxiety / depression scales will be performed by the PI who is a consultant neurologist.

All testing will be performed within the sleep and pulmonary department of the local tertiary hospital.

The same PI will be present while performing all the sleep and pulmonary testing to ensure accuracy and duplication of procedures and strict adherence to the study protocol.

The Control of Ventilation (COV) study is a standardised test performed in pulmonary function laboratories worldwide. The test involves the subject being seated and application of saturation probe for monitoring as well as a breathing apparatus with a tight seal round the mouth which measures carbon dioxide and oxygen concentrations. The patient is asked to breath normally while the investigators adjust the concentration of oxygen and carbon dioxide the patient inhales. In response to higher carbon dioxide levels and lower oxygen saturations, the respiratory rate should increase. This information is recorded on a digital graph format to interpret. This test is primarily used to determine the integrity of the central respiratory apparatus located within the brainstem. The test takes 30 - 40 minutes to complete with the subject being attached to the apparatus for approximately 15 minutes in total. The remainder of the time is spent setting up the test and apparatus by the scientists.

Control group

Active

Outcomes

Primary outcome [1]

Comparison in sleep function parameters for the Subthalamic nucleus (STN), caudal Zona Incerta (CZi) and Globus pallidus internus (GPi) DBS targets during ON stimulation and OFF stimulation.

Timepoint [1]

Patients in each DBS target group will be booked in for separate DBS ON and OFF assessments, within 6 months of each other and are used as direct comparisons for the purpose of the study. On the occasion of DBS OFF assessment, testing will occur 1 hour after the DBS device has been turned off. DBS ON assessments are booked as per schedule availability for the sleep clinic, within 6 months of the OFF assessment. The patient will attend this appointment with their DBS ON.

Primary outcome [2]

Comparison in pulmonary function parameters for the Subthalamic nucleus (STN), caudal Zona Incerta (CZi) and Globus pallidus internus (GPi) DBS targets during ON stimulation and OFF stimulation.

Timepoint [2]

Patients in each DBS target group will be booked in for pulmonary function testing at the respiratory clinic. Testing will be done with the stimulator ON and then repeated after the stimulator has been turned off for 1 hour. Patients have the option to have their ON and OFF assessments conducted on separate days, within 6 months of each other.

Secondary outcome [1]

Change in pulmonary outcomes for breathless DBS patients compared to medically managed breathless PD patients.

Timepoint [1]

Both DBS and medically managed patients will attend their pulmonary function test appointment having taken their usual levodopa dose. Assessment will occur 2 hours after the last dose of levodopa.

Secondary outcome [2]

Change in control of ventilation parameters in medication ON compared to OFF state, in medically managed (non-DBS) PD participants.

Timepoint [2]

This outcome is comparing pulmonary function tests on patient taking levodopa based therapy (without DBS in situ). Patients will be tested 2 hours after last levodopa dose (ON state), and prior to the next levodopa dose within the same dose cycle (OFF state) as direct comparison.

Secondary outcome [3]

Change in non-motor symptoms in DBS ON compared to OFF state for patients with STN DBS.

Timepoint [3]

Patients in the STN DBS target group will complete non-motor symptom questionnaires following their separate DBS ON and OFF sleep study assessments (within 6 months of each other).

Secondary outcome [4]

Change in non-motor symptoms in DBS ON compared to OFF state for patients with CZi DBS.

Timepoint [4]

Patients in the CZi DBS target group will complete non-motor symptom questionnaires following their separate DBS ON and OFF sleep study assessments (within 6 months of each other).

Secondary outcome [5]

Change in non-motor symptoms in DBS ON compared to OFF state for patients with GPi DBS.

Timepoint [5]

Patients in the GPi DBS target group will complete non-motor symptom questionnaires following their separate DBS ON and OFF sleep study assessments (within 6 months of each other).

Secondary outcome [6]

Change in motor symptoms in DBS ON compared to OFF state for patients with STN DBS.

Timepoint [6]

Patients in the STN DBS target group will complete motor assessment using the UPDRS (motor part 3) following their separate DBS ON and OFF sleep study assessments. The ON and OFF assessment will be scheduled within 6 months of each other.

Secondary outcome [7]

Change in motor symptoms in DBS ON compared to OFF state for patients with GPi DBS.

Timepoint [7]

Patients in the GPi DBS target group will complete motor assessment using the UPDRS (motor part 3) following their separate DBS ON and OFF sleep study assessments. The ON and OFF assessment will be scheduled within 6 months of each other.

Secondary outcome [8]

Change in motor symptoms in DBS ON compared to OFF state for patients with CZi DBS.

Timepoint [8]

Patients in the CZi DBS target group will complete motor assessment using the UPDRS (motor part 3) following their separate DBS ON and OFF sleep study assessments. The ON and OFF assessment will be scheduled within 6 months of each other.

Secondary outcome [9]

Change in cognition in DBS ON compared to OFF state for patients with STN DBS.

Timepoint [9]

Patients in the STN DBS target group will complete a cognitive assessment following their separate DBS ON and OFF sleep study assessments. The ON and OFF assessment will be scheduled within 6 months of each other.

Secondary outcome [10]

Change in cognition in DBS ON compared to OFF state for patients with CZi DBS.

Timepoint [10]

Patients in the CZi DBS target group will complete a cognitive assessment following their separate DBS ON and OFF sleep study assessments. The ON and OFF assessment will be scheduled within 6 months of each other.

Secondary outcome [11]

Change in cognition in DBS ON compared to OFF state for patients with GPi DBS.

Timepoint [11]

Patients in the GPi DBS target group will complete a cognitive assessment following their separate DBS ON and OFF sleep study assessments. The ON and OFF assessment will be scheduled within 6 months of each other.

Secondary outcome [12]

Change in psychological symptoms in DBS ON compared to OFF state for patients with STN DBS.

Timepoint [12]

Patients in the STN DBS target group will complete the psychological questionnaire assessment following their separate DBS ON and OFF sleep study assessments. The ON and OFF assessment will be scheduled within 6 months of each other.

Secondary outcome [13]

Change in psychological symptoms in DBS ON compared to OFF state for patients with CZi DBS.

Timepoint [13]

Secondary outcome [14]

Change in psychological symptoms in DBS ON compared to OFF state for patients with GPi DBS.

Timepoint [14]

Secondary outcome [15]

Change in non-motor symptoms in DBS ON compared to OFF state for patients with STN DBS.

Timepoint [15]

Patients in the STN DBS target group will complete non-motor sleep symptom questionnaire following their separate DBS ON and OFF sleep study assessments (within 6 months of each other).

Secondary outcome [16]

Change in non-motor symptoms in DBS ON compared to OFF state for patients with CZi DBS.

Timepoint [16]

Patients in the CZi DBS target group will complete non-motor sleep symptom questionnaire following their separate DBS ON and OFF sleep study assessments (within 6 months of each other).

Secondary outcome [17]

Change in non-motor symptoms in DBS ON compared to OFF state for patients with GPi DBS.

Timepoint [17]

Patients in the GPi DBS target group will complete non-motor sleep symptom questionnaire following their separate DBS ON and OFF sleep study assessments (within 6 months of each other).

Eligibility

Key inclusion criteria

For DBS PD patients:
• Clinical diagnosis of Parkinson’s disease made by a Movement disorder specialist using the Movement Disorder Society criteria
• DBS insertion of at least 1 year duration
• Male or female sex aged between 50 to 80 years
• Ability to tolerate OFF stimulation of up to a period of 14 hours for sleep assessments
• Ability to tolerate OFF stimulation of up to 4 hours for pulmonary assessments
• Able to attend hospital on up to four separate visits for study duration
• Language skills to read, process and communicate the motor, and non-motor aspects of their disease using the questionnaires included in the study protocol
• Physical capacity to perform the cardiopulmonary testing
• Functional and mental ability to understand the risks of the sleep study and ensure safety to tolerate the overnight sleep study which involves an unfamiliar environment

For medically managed PD patients:
• Clinical diagnosis of Parkinson’s disease made by a Movement disorder specialist using the Movement Disorder Society criteria
• PD symptoms of at least 4 years duration
• Male or female sex aged between 50 to 80 years
• Able to attend hospital on up to four separate visits for study duration
• Language skills to read, process and communicate the motor, and non-motor aspects of their disease using the questionnaires included in the study protocol
• Physical capacity to perform the cardiopulmonary testing
• Functional and mental ability to understand the risks of the sleep study and ensure safety to tolerate the overnight sleep study which involves an unfamiliar environment

For healthy controls:
• Male or female sex aged between 50 to 80 years
• Able to attend hospital on up to four separate visits for study duration
• Language skills to read, process and communicate the motor, and non-motor aspects of their disease using the questionnaires included in the study protocol
• Physical capacity to perform the cardiopulmonary testing
• Functional and mental ability to understand the risks of the sleep study and ensure safety to tolerate the overnight sleep study which involves an unfamiliar environment

Minimum age

50 Years

Maximum age

80 Years

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

For DBS PD patients:
• Pre-existing respiratory diagnosis/dysfunction (i.e. COPD, asthma, interstitial lung disease, pulmonary embolus, obstructive sleep apnoea, pleural effusion, lung malignancy)
• Other comorbid conditions likely to contribute to breathlessness (i.e. heart failure, morbid obesity, symptomatic anaemia)
• Current smokers
• Severe dyskinesia, bradykinesia or tremor OFF stimulation who are likely to not tolerate OFF stimulation
• Coexisting cognitive impairment / dementia, defined as Montreal cognitive assessment (MoCA) less than 26, who will not be able to give informed consent or adhere to study protocols with accuracy
• Patients under the age of 50 years of age.
• Participants who are employees within the researcher’s department including The Perron Institute or the Respiratory department at SCGH

For medically managed PD patients:
• Pre-existing respiratory diagnosis/dysfunction (i.e. COPD, asthma, interstitial lung disease, pulmonary embolus, obstructive sleep apnoea, pleural effusion, lung malignancy)
• Other comorbid conditions likely to contribute to breathlessness (i.e. heart failure, morbid obesity, symptomatic anaemia)
• Current smokers
• Severe dyskinesia, bradykinesia or tremor OFF stimulation who are likely to not tolerate OFF stimulation
• Coexisting cognitive impairment / dementia, defined as Montreal cognitive assessment (MoCA) less than 26, who will not be able to give informed consent or adhere to study protocols with accuracy
• Patients under the age of 50 years of age.
• Participants who are employees within the researcher’s department including The Perron Institute or the Respiratory department at SCGH

For healthy controls:
• Pre-existing respiratory diagnosis/dysfunction (i.e. COPD, asthma, interstitial lung disease, pulmonary embolus, obstructive sleep apnoea, pleural effusion, lung malignancy)
• Other comorbid conditions likely to contribute to breathlessness (i.e. heart failure, morbid obesity, symptomatic anaemia)
• Current smokers
• Coexisting cognitive impairment / dementia, defined as Montreal cognitive assessment (MoCA) less than 26, who will not be able to give informed consent or adhere to study protocols with accuracy
• Patients under the age of 50 years of age.
• Participants who are employees within the researcher’s department including The Perron Institute or the Respiratory department at SCGH

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

This is a pilot observational study only

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

2/05/2020

Date of last participant enrolment

Anticipated

2/02/2028

Actual

Date of last data collection

Anticipated

2/02/2028

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Perron Institute for Neurological and Translational Science - Nedlands

Recruitment hospital [2]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Dr Srimathy Vijayan: Perron Institute for Neurological and Translational Science

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Human Research Ethics Committee H

Ethics committee address [1]

https://bellberry.com.au/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/04/2019

Approval date [1]

05/07/2019

Ethics approval number [1]

Summary

Brief summary

Deep brain stimulation (DBS) is a treatment for Parkinson's disease that uses a small implanted device to send electrical signals to specific areas of the brain, helping to control movement symptoms. While DBS is known to improve movement, less is known about how it affects sleep quality and breathing (pulmonary function) in people with Parkinson's disease.

This pilot study aims to find out what types of sleep and breathing problems occur in people with Parkinson's disease who have a DBS device. There are three common brain locations where the DBS device can be placed, and this study will compare how each of these affects sleep and breathing.

Participants who already have a DBS device will attend the hospital for an overnight sleep study, and separately for breathing tests, both with their DBS switched on and again with it switched off, so researchers can see the difference stimulation makes. A comparison group of people with Parkinson's disease who don't have DBS (managed with medication only) will also complete the breathing tests, to help researchers understand whether any breathing changes are related to the DBS device itself, to Parkinson's disease more broadly, or to something else.

By better understanding how DBS affects sleep and breathing, this research aims to help doctors make more informed decisions about DBS placement and management, and ultimately improve quality of life for people living with Parkinson's disease.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Srimathy Vijayan

Address

QEII Medical Centre, 8 Verdun Street, Nedland WA 6009

Country

Australia

Phone

+61 8 6457 0200

Fax

[email protected]

Contact person for public queries

Name

Dr Srimathy Vijayan

Address

QEII Medical Centre, 8 Verdun Street, Nedland WA 6009

Country

Australia

Phone

+61 8 6457 0200

Fax

[email protected]

Contact person for scientific queries

Name

Dr Srimathy Vijayan

Address

QEII Medical Centre, 8 Verdun Street, Nedland WA 6009

Country

Australia

Phone

+61 8 6457 0200

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor

What individual participant data might be shared?

• All de-identified individual participant data

What types of analyses could be done with individual participant data?

• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
Not yet decided

Where can requests to access individual participant data be made, or data be obtained directly?

• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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