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Trial registered on ANZCTR


Registration number
ACTRN12625000727448
Ethics application status
Approved
Date submitted
21/06/2025
Date registered
8/07/2025
Date last updated
8/07/2025
Date data sharing statement initially provided
8/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of sleep restriction on breathlessness in chronic obstructive
pulmonary disease
Scientific title
The effects of sleep restriction on breathlessness in chronic obstructive
pulmonary disease patients aged 40 and over
Secondary ID [1] 314710 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breathlessness 337903 0
Chronic obstructive pulmonary disease 337902 0
Condition category
Condition code
Respiratory 334233 334233 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sleep restriction (4 hour total sleep time) on one night, from midnight to 4am (one single continuous window).
This intervention occurs on a single night.
Participants will be asked to abstain from drinking coffee and/or napping from 4am until the exercise test, which will occur between 8-9am on the same day. A taxi will transport them to/from the hospital where the exercise test is conducted.

A sleep tracker (Withings Sleep Analyzer) will be in place under each participant's mattress to monitor sleep duration and timing.

As a crossover trial, there will be a minimum 7 day period between sleep intervention nights (one night is restricted to four hours, the other is unrestricted).

The cardiopulmonary exercise test is performed on a cycle ergometer.
Intervention code [1] 331317 0
Behaviour
Intervention code [2] 331364 0
Lifestyle
Comparator / control treatment
Participants' usual sleep duration.
Control group
Active

Outcomes
Primary outcome [1] 341898 0
Breathlessness
Timepoint [1] 341898 0
At isotime during constant-load cardiopulmonary exercise testing the morning after intervention. Isotime refers to the final two minute interval of exercise completed by a given participant during the constant work-rate cardiopulmonary exercise test. The difference in breathlessness as measured by Borg score reported by participants during this final 2-minute window will be analysed. Borg score will be measured every two minutes during exercise, to ensure that a measurement in the final two minutes of exercise is recorded. This measurement allows us to analyse differences in the perception of breathlessness at near-maximum exertion, which we expect to be different between interventions. The duration of exercise time will differ between participants, so an 'isotime' measurement allows us to test perception of breathlessnesss near maximal exertion whilst accounting for differences in total exercise time.
Primary outcome [2] 341899 0
Exercise endurance time
Timepoint [2] 341899 0
End of the constant-load cardiopulmonary exercise test the morning after intervention.
Secondary outcome [1] 448909 0
Alertness
Timepoint [1] 448909 0
At baseline and on the morning after intevention
Secondary outcome [2] 448905 0
Reason for stopping exercise
Timepoint [2] 448905 0
End of cardiopulmonary exercise test
Secondary outcome [3] 448906 0
Recovery time
Timepoint [3] 448906 0
At end of cardiopulmonary exercise testing
Secondary outcome [4] 448902 0
FEV1:FVC ratio
Timepoint [4] 448902 0
After cardiopulmonary exercise testing the morning following the intervention
Secondary outcome [5] 448900 0
Forced expiratory volume in one second (FEV1)
Timepoint [5] 448900 0
After cardiopulmonary exercise testing the morning following the intervention
Secondary outcome [6] 448901 0
Forced vital capacity (FVC)
Timepoint [6] 448901 0
After cardiopulmonary exercise testing the morning following intervention
Secondary outcome [7] 448908 0
Sleepiness
Timepoint [7] 448908 0
At baseline and on the morning after intervention
Secondary outcome [8] 448904 0
Ventilatory threshold
Timepoint [8] 448904 0
During cardiopulmonary exercise testing
Secondary outcome [9] 448903 0
Maximum oxygen consumption (VO2Max)
Timepoint [9] 448903 0
End of the contant-load cardiopulmonary exercise test the morning following the intervention
Secondary outcome [10] 448907 0
Total sleep time
Timepoint [10] 448907 0
Intervention night and over the 7 nights prior to cardiopulmonary exercise tests

Eligibility
Key inclusion criteria
- COPD, defined as a post-bronchodilator FEV1/FVC ratio of <0.70 or less than the lower
limit of normal
- Self-reported nightly sleep duration of at least 6 hours
- Chronic breathlessness (as defined by a modified Medical Research Council (mMRC)
Dyspnea Scale score of 3 or more despite optimal inhaled therapy
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Moderate to severe COPD exacerbation in the past 6 weeks
- Change in COPD medication in the past 7 days (except as needed medications)
- Asthma
- Regular use of sedatives or hypnotics for sleep
- Pregnant or planning pregnancy during the study
- Breathlessness due to any other systemic condition
- Contraindication to CPET (uncontrolled ischemic heart disease; syncope; uncontrolled
arrhythmia; acute myocarditis/pericarditis; acute pulmonary edema; severe cardiac valve stenosis; inability to follow instructions; exercise-induced oxyhemoglobin desaturation to <80% on room air)
- Supplemental oxygen use
- Attention-critical occupation (e.g. commercial driver etc.)
- Inability to adhere to the sleep restriction protocol
- Any condition that in the investigator’s opinion would present an unreasonable risk to
the participant, or which would interfere with their participation in the study or
confound data interpretation

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/07/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 28125 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 44331 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 319262 0
University
Name [1] 319262 0
University of Adelaide
Country [1] 319262 0
Australia
Primary sponsor type
Hospital
Name
Central Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 321736 0
None
Name [1] 321736 0
Address [1] 321736 0
Country [1] 321736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317841 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 317841 0
Ethics committee country [1] 317841 0
Australia
Date submitted for ethics approval [1] 317841 0
17/01/2025
Approval date [1] 317841 0
07/03/2025
Ethics approval number [1] 317841 0
2025/HRE00010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142322 0
Dr Thomas Altree
Address 142322 0
Respiratory Unit, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, South Australia 5011
Country 142322 0
Australia
Phone 142322 0
+61478262861
Fax 142322 0
Email 142322 0
[email protected]
Contact person for public queries
Name 142323 0
Thomas Altree
Address 142323 0
Respiratory Unit, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, South Australia 5011
Country 142323 0
Australia
Phone 142323 0
+61882226000
Fax 142323 0
Email 142323 0
[email protected]
Contact person for scientific queries
Name 142324 0
Thomas Altree
Address 142324 0
Respiratory Unit, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, South Australia 5011
Country 142324 0
Australia
Phone 142324 0
+61882226000
Fax 142324 0
Email 142324 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    2025HRE00010 Altree - APPROVAL Letter.pdf.pdf


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.