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Trial registered on ANZCTR


Registration number
ACTRN12612001136897
Ethics application status
Approved
Date submitted
19/10/2012
Date registered
24/10/2012
Date last updated
5/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Obstructive sleep apnoea and related symptoms study
Scientific title
In participants with Obstructive Sleep Apnoea (OSA) and depression, is Continuous Positive Airway Pressure (CPAP) effective in reducing the symptoms associated with depression?
Secondary ID [1] 281192 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 287372 0
Obstructive Sleep Apnoea 287397 0
Condition category
Condition code
Mental Health 287706 287706 0 0
Depression
Respiratory 288003 288003 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapeutic Continuous Positive Airway Pressure plus humidification for 12 weeks.

Treatment Arm 1 - Diagnosed depression* + obstructive sleep apnoea
Treatment Arm 2 - No diagnosed depression* + obstructive sleep apnoea

*Depression or no depression will be based on DSM-IV diagnostic criteria for mood disorders as assessed by the SCID Mood Episodes module A.

CPAP involves the use of a machine during sleep that pumps air under gentle pressure, via a tube, to a mask that covers the nose (or mouth and nose). The air pressure acts to hold the upper airway open so that it does not collapse during sleep.

Therapeutic CPAP therapy will involve the use of a CPAP device with variable pressure setting for the first week. After 1 week, a fixed-pressure CPAP will be prescribed, based on the pressure required to control 95% of periods of apnoea or hypopnoea. Participants will receive the prescribed pressure for 11 weeks. Participants will be encouraged to use the therapeutic CPAP device during periods of sleep each night. Hours of use, and days used will be recorded.
Intervention code [1] 285655 0
Treatment: Devices
Intervention code [2] 285907 0
Treatment: Other
Comparator / control treatment
Sham (sub-therapeutic) Continuous Positive Airway Pressure plus humidificiation for 12 weeks.

Treatment Arm 3 - Diagnosed depression* + obstructive sleep apnoea
Treatment Arm 4 - No diagnosed depression* + obstructive sleep apnoea

*Depression or no depression will be based on DSM-IV diagnostic criteria for mood disorders as assessed by the SCID Mood Episodes module A.

Sham CPAP is a modified CPAP device that provides a sub-therapeutic pressure at the mask (less than 1cm H20). The Sham CPAP device will be indistinguishable from the therapeutic CPAP device. Participants will receive the sub-therapeutic pressure weeks 1-12. Participants will be encouraged to use the sham CPAP device during periods of sleep each night. Hours of use, and days used will be recorded.
Control group
Placebo

Outcomes
Primary outcome [1] 287949 0
Reduction in Hamilton Depression Scale of 4 or more.
Timepoint [1] 287949 0
4, 8, 12 weeks following randomisation
Primary outcome [2] 287953 0
Clinician-rated moderate or marked improvement in overall well-being from baseline as per the Clinical Global Impression scale
Timepoint [2] 287953 0
4, 8, 12 weeks following randomisation
Secondary outcome [1] 299107 0
Severity of anxiety as per the Generalised Anxiety Disorder Scale
Timepoint [1] 299107 0
4, 8, 12 weeks following randomisation
Secondary outcome [2] 299110 0
Epworth Sleepiness Score
Timepoint [2] 299110 0
1, 3, 4, 6, 8, 12 weeks following randomisation
Secondary outcome [3] 299111 0
Sleep Apnoea Quality of Lilfe Index
Timepoint [3] 299111 0
4, 6, 8, 12 weeks following randomisation

Eligibility
Key inclusion criteria
Apnoea/hypopnoea index (AHI) greater than 15
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Central (non-obstructive) sleep apnoea.
Current or prior treatment for OSA, including: mandibular advancement splint; CPAP therapy; upper airway surgery; Provent Nasal Device (microvalve technology that provides expiratory positive airway pressure).
Participants who meet the DSM-IV diagnostic criteria for psychotic symptoms as assessed by the SCID Psychotic Screen modules B/C; or participants who meet the DSM-IV diagnostic criteria for substance abuse or co-morbid alcohol use as diagnosed by the SCID Substance Use Disorders module E,
within the 12 months prior to enrolment.
Participants who are actively suicidal as assessed by the Columbia Suicide Severity Rating Scale.

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)
Participants will be recruited entirely from the Sir Charles Gairdner Hospital Sleep Disorders Clinic with stratification for sex and diagnosed depression to ensure equal numbers of males and females, and depressed and non-depressed participants in each treatment arm.
Recruitment will occur in two stages:
Stage 1 100% of females and 50% of males will be invited to be screened. Males born in months 1, 3, 5, 7, 9, 11 will be invited to be screened.
Stage 2 Following written informed consent, and determination of depression status, 100% of depressed females; 42% of not depressed females (those born in months 1, 4, 7, 10, 12); 67% of depressed males (those born in months 3,5,7,9); and 50% of not depressed males (those born in months 1,7,11) will be randomised.
Recruitment across the strata will be reviewed following randomisation of 90 participants. In the event that proportions of males and females, depressed and not depressed are unequal, the recruitment process will be adjusted by varying the number of birth months used for recruitment.
In order to allow for possible seasonal effects on depression, it is aimed to recruit each of the above strata at a similar rate over the study period.
Based upon depression status, sex and birth month, participants will be allocated to a treatment group using a computer program, in accordance with a predetermined random computer-generated algorithm. The researcher who will conduct assessments at each visit will remain blinded as to the treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Within each stratum, a random computer-generated list of sequences will determine the randomisation sequence.
This will ensure balance in Therapeutic CPAP vs sham CPAP after each block. The randomisation sequence will be generated by off-site chief investigators.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2013
Actual
19/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285975 0
Government body
Name [1] 285975 0
National Health and Medical Research Council Australia
Country [1] 285975 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council Australia
Address
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 284807 0
None
Name [1] 284807 0
Address [1] 284807 0
Country [1] 284807 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288244 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 288244 0
Ethics committee country [1] 288244 0
Australia
Date submitted for ethics approval [1] 288244 0
10/11/2012
Approval date [1] 288244 0
04/06/2013
Ethics approval number [1] 288244 0
2012-042

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

Contacts
Principal investigator
Name 34689 0
Prof David Hillman
Address 34689 0
Department of Pulmonary Physiology and Sleep Medicine Level 5, G Block Sir Charles Gairdner Hospital Hospital Avenue Nedlands WA 6009
Country 34689 0
Australia
Phone 34689 0
61 (08) 9346 2222
Fax 34689 0
61 (0)8 9346 2034
Email 34689 0
David.Hillman@health.wa.gov.au
Contact person for public queries
Name 17936 0
Ms Peta Grayson
Address 17936 0
Department of Pulmonary Physiology and Sleep Medicine
Level 5, G Block Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009
Country 17936 0
Australia
Phone 17936 0
61 8 9346 2888
Fax 17936 0
61 8 9346 2034
Email 17936 0
Peta.Grayson@health.wa.gov.au
Contact person for scientific queries
Name 8864 0
Clinical Professor David Hillman
Address 8864 0
Department of Pulmonary Physiology and Sleep Medicine
Level 5, G Block Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009
Country 8864 0
Australia
Phone 8864 0
61 8 9346 2222
Fax 8864 0
61 8 9346 2034
Email 8864 0
David.Hillman@health.wa.gov.au

No information has been provided regarding IPD availability


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.