Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000733471
Ethics application status
Approved
Date submitted
28/05/2016
Date registered
3/06/2016
Date last updated
22/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does treatment of Obstructive Sleep Apnoea in patients with Mild Cognitive Impairment improve cognition and mood?
Scientific title
Effects of Positive Airway Pressure therapy on cognition and mood in patients with Obstructive Sleep Apnoea and Mild Cognitive Impairment
Secondary ID [1] 288664 0
Nil known
Universal Trial Number (UTN)
Trial acronym
COMM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 297851 0
Mild Cognitive Impairment 297852 0
Condition category
Condition code
Respiratory 298024 298024 0 0
Sleep apnoea
Mental Health 299020 299020 0 0
Other mental health disorders
Neurological 299021 299021 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1.
The STOP-bang questionnaire will be used in memory clinics to screening for patients who are at risk of having obstructive sleep apnoea (OSA). Patients with memory impairment and have a moderate-high risk of having OSA based on the questionnaire (STOP-bang score of 3 or more) will be invited to take part in Phase 1 which includes an overnight sleep study and a neuropsychological testing session. The overnight diagnostic sleep study will be conducted in-lab at the RMIT Sleep Laboratory, Bundoora or at-home with a portable sleep recording device by a trained sleep lab staff. On the following morning, a baseline 90-minute neuropsychological testing session will be conducted. The sleep study will be reviewed by the study's sleep physician. Participants with moderate to severe obstructive sleep apnoea and recommended CPAP by the study's sleep physician will proceed into Phase 2.

Phase 2.
Auto Positive Airway Pressure (AutoPAP) therapy will be used as the intervention. Positive airway pressure therapy involves a AutoPAP machine with three basic parts: (i) an air pump; (ii) a mask that fits over the nose or/and mouth and; (iii) a tube that connects the machine and mask. The AutoPAP machine will be used daily during sleep for 3 months.

An introductory Auto CPAP session along with a mask fitting session will be conducted by trained sleep lab staff. Participants will be required to use the machine at home daily following the initial 30-minute introductory session. The AutoPAP machine adjusts and varies the pressure breath to breath throughout the night automatically, with a minimum pressure of 4 and maximum pressure of 20.

Participants will be followed-up via phone calls throughout the 3-month intervention to troubleshoot issues and encourage optimal usage. Phone calls will be conducted on the day after first AutoPAP usage followed by, weekly phone calls for the first month and monthly phone calls for the next two months.
Intervention code [1] 294077 0
Treatment: Devices
Intervention code [2] 294934 0
Early detection / Screening
Intervention code [3] 294935 0
Diagnosis / Prognosis
Comparator / control treatment
This study is a randomised partial cross-over study. The study intervention will be compared against those who are not receiving the positive airway pressure treatment. The control group will be offered CPAP intervention 3 months after the baseline test-battery was administered. Prior to starting the intervention, the control group will be required to undergo a second test-battery.
Control group
Active

Outcomes
Primary outcome [1] 297541 0
Addenbrooke's Cognitive Examination-Revised (ACE-R) score
Timepoint [1] 297541 0
Baseline, and at 3 months after intervention commencement
Primary outcome [2] 297542 0
Geriatrics Depression Scale (GDS) score
Timepoint [2] 297542 0
Baseline, and at 3 months after intervention commencement
Primary outcome [3] 298497 0
STOP-bang questionnaire score (Prevalence of those who are at low, moderate and high risk of having Obstructive Sleep Apnoea)
Timepoint [3] 298497 0
Phase prior to baseline
Secondary outcome [1] 321351 0
Rey-Osterrieth complex figure test (ROCF) score
Timepoint [1] 321351 0
Baseline, and at 3 months after intervention commencement
Secondary outcome [2] 321352 0
Verbal Paired Associates score from the Wechsler Memory Scale (WMS-IV)
Timepoint [2] 321352 0
Baseline, and at 3 months after intervention commencement
Secondary outcome [3] 321353 0
Logical Memory score from the Wechsler Memory Scale (WMS-IV)
Timepoint [3] 321353 0
Baseline, and at 3 months after intervention commencement
Secondary outcome [4] 321354 0
Epworth Sleepiness Scale (ESS) score
Timepoint [4] 321354 0
Baseline, and at 3 months after intervention commencement
Secondary outcome [5] 321355 0
Pittsburgh Sleep Quality Index (PSQI) score
Timepoint [5] 321355 0
Baseline, and at 3 months after intervention commencement
Secondary outcome [6] 321356 0
Hospital Anxiety-Depression Scale (HADS) score
Timepoint [6] 321356 0
Baseline, and at 3 months after intervention commencement
Secondary outcome [7] 321357 0
Coding and Symbol Search sub-tests score from the Weschler Adult Intelligence Scale (WAIS-IV)
Timepoint [7] 321357 0
Baseline, and at 3 months after intervention commencement
Secondary outcome [8] 321358 0
Digit Span sub-test score from the Wechsler Adult Intelligence Scale (WAIS-IV)
Timepoint [8] 321358 0
Baseline, and at 3 months after intervention commencement
Secondary outcome [9] 321359 0
Trail Making A & B test score
Timepoint [9] 321359 0
Baseline, and at 3 months after intervention commencement

Eligibility
Key inclusion criteria
The key inclusion criteria includes untreated Obstructive Sleep Apnoea with an Apnoea-Hypopnoea Index (AHI) of 15 or more, clinically significant memory impairment and English fluency.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if memory impairment is due to stroke, epilepsy or traumatic brain injury. Other exclusion criteria includes sleep disorders other than OSA, learning disability and alcohol or drug dependence .

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)
Allocation involves contacting the holder of the allocation schedule who is at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Partial-crossover
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
.GPower (version 3.1.7) analysis was conducted to calculate the sample size required to detect statistical significance with 70% power, alpha = .05, a small to medium effect size f = .20, and an assumed correlation of 0.5, based on previous evaluations of CPAP intervention for OSA in elderly patients. This indicated that a sample size of N=30 (i.e. 15 participants in each group) is required. To account for attrition, we have included 20% additional participants, thus require N = 36 (18 participants in each group).

The statistical analysis will be a mixed effects analysis of variance (ANOVA), which will account for systemic individual difference in outcome measures between the control and patient group for Phase 1, and between the immediate CPAP and waitlist group in Phase 2.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/11/2015
Date of last participant enrolment
Anticipated
1/08/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5726 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 5727 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 13203 0
3084 - Heidelberg
Recruitment postcode(s) [2] 13204 0
3076 - Epping
Recruitment postcode(s) [3] 13205 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 293503 0
University
Name [1] 293503 0
RMIT University
Country [1] 293503 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
RMIT University, Plenty Road, Bundoora VIC 3083
Country
Australia
Secondary sponsor category [1] 292332 0
None
Name [1] 292332 0
Address [1] 292332 0
Country [1] 292332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294947 0
Northern Health Human Research Ethics Committee
Ethics committee address [1] 294947 0
Northern Health,
The Northern Hospital,
185 Cooper Street
Epping Victoria 3076
Ethics committee country [1] 294947 0
Australia
Date submitted for ethics approval [1] 294947 0
26/05/2015
Approval date [1] 294947 0
01/06/2015
Ethics approval number [1] 294947 0
HREC/15/NH/7
Ethics committee name [2] 294948 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 294948 0
L8 Harold Stokes Building, Austin Health
145 Studley Road, Heidelberg, 3084 VIC
Ethics committee country [2] 294948 0
Australia
Date submitted for ethics approval [2] 294948 0
11/09/2015
Approval date [2] 294948 0
03/12/2015
Ethics approval number [2] 294948 0
HREC/15/Austin/393
Ethics committee name [3] 294949 0
RMIT Human Research Ethics Committee
Ethics committee address [3] 294949 0
RMIT University
GPO Box 2476
Building 91, Level 2
MELBOURNE VIC 3001
Ethics committee country [3] 294949 0
Australia
Date submitted for ethics approval [3] 294949 0
10/08/2015
Approval date [3] 294949 0
16/09/2015
Ethics approval number [3] 294949 0
19269

Summary
Brief summary
Sleep-related breathing disorder has been commonly reported in elderly individuals with mild cognitive impairment. This project is interested in examining the prevalence of Obstructive Sleep Apnoea (OSA) in patients attending the Cognitive, Dementia, and Memory Service (CDAMS) at Northern Health and Austin Health. Also, this project aims to determine if 3 months of CPAP therapy for OSA in patients with memory impairments improves mood and memory.

Firstly, patients attending CDAMS with memory impairment will be screened for OSA and patients who have a high risk of OSA will be invited to take part in Phase 1. Interested participants will be invited to attend the RMIT Sleep Laboratory for a 90-minute neuropsychological testing session and an overnight diagnostic polysomnography (PSG). Healthy age-matched controls will also undergo the same neuropsychological testing and overnight PSG to investigate differences in cognition and memory of individuals with memory impairment and healthy individuals.

Patients who are diagnosed with OSA and recommended Continuous Positive Airway Pressure (CPAP) by the study physician will be invited to participate in Phase 2 the project. Participants will be randomised to either an immediate CPAP group or a 3-month wait-list group. Participants in the immediate CPAP condition will be given an auto-titrating PAP machine and asked to use their CPAP at home. After 3 months of CPAP therapy, participants will attend a second appointment at the Sleep Laboratory to complete follow-up tests and questionnaires. Patients in the wait-list condition will commence CPAP after 3 months and the same follow-up procedures will be followed as per the immediate CPAP group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61394 0
Dr Melinda Jackson
Address 61394 0
RMIT University
School of Health and Biomedical Sciences
RMIT University, PO Box 71
Bundoora, Vic. 3083, Australia
Country 61394 0
Australia
Phone 61394 0
+613 9925 7564
Fax 61394 0
Email 61394 0
[email protected]
Contact person for public queries
Name 61395 0
Miss V Vien Lee
Address 61395 0
RMIT University
School of Health and Biomedical Sciences
RMIT University, PO Box 71
Bundoora, Vic. 3083, Australia
Country 61395 0
Australia
Phone 61395 0
+613 9925 6548
Fax 61395 0
Email 61395 0
[email protected]
Contact person for scientific queries
Name 61396 0
Dr Melinda Jackson
Address 61396 0
RMIT University
School of Health and Biomedical Sciences
RMIT University, PO Box 71
Bundoora, Vic. 3083, Australia
Country 61396 0
Australia
Phone 61396 0
+613 9925 7564
Fax 61396 0
Email 61396 0
[email protected]

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

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