The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01826513




Registration number
NCT01826513
Ethics application status
Date submitted
1/04/2013
Date registered
8/04/2013
Date last updated
27/03/2017

Titles & IDs
Public title
AutoSet for Her Clinical Trial Protocol
Scientific title
AutoSet for Her Clinical Trial Protocol
Secondary ID [1] 0 0
MA13245678
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Standard AutoSet algorithm
Treatment: Devices - Modified AutoSet algorithm

Experimental: Unblinded Investigational Arm - Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).

Active Comparator: Standard AutoSet algorithm - Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.

Experimental: Modified AutoSet algorithm - Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.


Treatment: Devices: Standard AutoSet algorithm
An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.

Treatment: Devices: Modified AutoSet algorithm
An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnoea Hypopnoea Index (AHI) - Number of apnoeas and hypopnoeas per hour of sleep
Timepoint [1] 0 0
1 day
Primary outcome [2] 0 0
Oxygen Desaturation Index (ODI) - Number of oxygen desaturations per hour of sleep
Timepoint [2] 0 0
1 day
Secondary outcome [1] 0 0
Sleep Efficacy - Sleep time divided by total time available for sleep
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
Wake After Sleep Onset Time - Time awake in minutes after initial sleep onset
Timepoint [2] 0 0
1 day
Secondary outcome [3] 0 0
Time Taken to Fall Asleep - Time in minutes taken to fall alseep
Timepoint [3] 0 0
1 day
Secondary outcome [4] 0 0
Number of Spontaneous Arousals - Number of spontaneous arousals occurring over the entire total sleep time
Timepoint [4] 0 0
1 day
Secondary outcome [5] 0 0
Number of Hypopnoeas - Total number of hypopnoeas occurring in the total sleep time
Timepoint [5] 0 0
1 day
Secondary outcome [6] 0 0
Number of Obstructive Apnoeas - Total number of obstructive apnoeas occurring in the total sleep time
Timepoint [6] 0 0
1 day
Secondary outcome [7] 0 0
Number of Central Apnoeas - Total number of central apnoeas occurring in the total sleep time
Timepoint [7] 0 0
1 day
Secondary outcome [8] 0 0
Oxygen Saturation - Oxygen saturation recorded in the total sleep time
Timepoint [8] 0 0
1 day
Secondary outcome [9] 0 0
Percentage of Total Sleep Time Spent in Each Sleep Stage - Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)
Timepoint [9] 0 0
1 day
Secondary outcome [10] 0 0
Number of Respiratory Event Related Arousals - Total number of respiratory event related arousals over the entire sleep period
Timepoint [10] 0 0
1 day

Eligibility
Key inclusion criteria
- Pre-menopausal females aged = 18 years

- Current positive airway pressure (PAP)(CPAP or APAP) therapy user with 'current'
defined as on PAP therapy for at least 1 month prior to study entry

- Diagnostic PSG available

- Diagnosis of mild-moderate OSA (AHI = 30)

- Participants willing and able to give written informed consent
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants currently using Bi-level PAP

- Participants currently using supplemental oxygen

- Participants who are pregnant

- Subjects who have a pre existing lung disease/ condition that would predispose them to
pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years)
case of pneumonia or lung infection; lung injury)

- Participants who the researcher believes are unsuitable for inclusion because either:

- they do not comprehend English

- they are unable to provide written informed consent

- they are physically unable to comply with the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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 receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
West Australian Sleep Disorders Research Institute - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Western Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy and user preference of the Newport
AutoSet for Her in female obstructive sleep apnea (OSA) patients.

Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen
desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm.

User preference will be evaluated by subjective feedback relating to comfort, ease of falling
asleep, sleep disturbance and feeling of being refreshed.
Trial website
https://clinicaltrials.gov/show/NCT01826513
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Eastwood, MBBS FRACP
Address 0 0
Centre for Sleep Science, University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications