Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000442606
Ethics application status
Approved
Date submitted
22/04/2014
Date registered
29/04/2014
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of Obstructive Sleep Apnoea for Cognitive Decline in Mild Cognitive Impairment
Scientific title
Treatment with Continuous Positive Airway Pressure in people aged 50-80 years with Obstructive Sleep Apnoea and Mild Cognitive Impairment to reduce the rate of cognitive decline
Secondary ID [1] 284430 0
Nil known
Universal Trial Number (UTN)
U1111-1155-7875
Trial acronym
MCI-CPAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 291634 0
Mild Cognitive Impairment (MCI) 291635 0
Condition category
Condition code
Respiratory 292017 292017 0 0
Sleep apnoea
Neurological 292018 292018 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being studied in this trial is Continuous Positive Airway
Pressure (CPAP), which is the current gold-standard treatment for Obstructive Sleep Apnea (OSA). CPAP involves wearing a mask around the nose, mouth or face, which is connected via a tube to a device that creates an internal air pressure. This air pressure is then transmitted through the tube at a continuous pressure and into the mask worn by the participant every night during sleep.
CPAP dose is set by the air pressure emitted from the mask, and this will be determined by a pressure determination sleep test performed at the
Woolcock Institute of Medical Research, in accordance with clinical practices. The duration of CPAP treatment will be for three months.

Compliance with treatment will be measured using the built-in CPAP smartcard that will measure how long (in hours) the CPAP pump was used by the patient each time it was switched on. This information will be assessed during compliance appointments with an experienced CPAP therapist at regular intervals throughout the treatment period.
Additionally, self-reported compliance will be assessed by a Study
Researcher during structured telephone interviews conducted at Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16, 18, 20 and 24 during the active CPAP treatment period.
Intervention code [1] 289181 0
Treatment: Devices
Comparator / control treatment
No treatment.

This trial is a two-way cross-over design. Each treatment period will be three months duration, with a one-week wash-out period between the two treatment periods.
Control group
Active

Outcomes
Primary outcome [1] 291906 0
Processing speed as assessed by Symbol Digit Modalities Test
Timepoint [1] 291906 0
Baseline, and once twelve weeks of each treatment period has been completed.
Primary outcome [2] 291907 0
Executive function as assessed by the Trails B and Stroop Test components of a standard Neuropsychological battery.
Timepoint [2] 291907 0
Baseline, and once twelve weeks of each treatment period has been completed.
Secondary outcome [1] 307791 0
Mood as assessed by Geriatric Depression Scale
Timepoint [1] 307791 0
Baseline, and once twelve weeks of each treatment period has been completed.
Secondary outcome [2] 307792 0
Sleep quality and daytime sleepiness as assessed by actigraphy and the Pittsburg Sleep Quality Index and Epworth Sleepiness Scale.
Timepoint [2] 307792 0
Baseline, and once twelve weeks of each treatment period has been completed.
Secondary outcome [3] 307793 0
Magnetic resonance spectroscopy markers of brain integrity.
Timepoint [3] 307793 0
Baseline, and once twelve weeks of the first treatment period has been completed.
Secondary outcome [4] 307857 0
Memory as assessed by the Rey Auditory Verbal Learning Test
Timepoint [4] 307857 0
Baseline, and once twelve weeks of each treatment period has been completed.

Eligibility
Key inclusion criteria
To be eligible, participants must:
1. Have the presence of at least moderate OSA as defined by an AHI of greater than or equal to 15 as defined by PSG using the criteria of 4% O2 desaturation for events.
2. Have a diagnosis of single- or multi-domain Mild Cognitive Impairment (MCI) as determined by neuropsychological examination using a standardized research neuropsychological battery.
3. Have stability of at least four weeks on permitted medications (i.e. medications known not to affect sleep architecture or circadian rhythms).
4. Be fluent in English
5. Be willing and able to complete baseline, three month and six month outcome measures
6. Be willing to send in CPAP Smartcard for adherence testing
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have:
1. Suspected dementia or a score of <24 on the Mini-Mental State Examination
2. A history of cerebrovascular events (e.g., stroke, TIA)
3. Planned shift-work or transmeridian travel within timeline of study (six months from baseline)
4. A diagnosis of neurological disorders (e.g. Parkinson's Disease, Epilepsy, Multiple Sclerosis)
5. Head trauma with associated loss of consciousness > 30mins or head injury with persisting cognitive deficits
6. Psychiatric disorders including current major depression; Bipolar Disorder (I and II); schizophrenia
7. Been taking tricyclic antidepressants (TCAs), Monoamine Oxidase Inhibitors (MAOIs), benzodiazepines, sedative hypnotics, antipsychotics, mood stabilisers, modafinil or stimulants, cholinesterase inhibitors or medications known to affect sleep architecture and/or circadian rhythms (e.g. Lithium)
8. Current substance abuse or dependence (alcohol and/or other illicit substances)
9. Any significant systematic illness or medical condition that may hinder compliance with treatment protocol
10. Any current known conditions that may increase short-term risk from untreated OSA
11. Other known clinically significant sleep disorders (e.g. narcolepsy)
12. Been currently receiving CPAP or bi-level pressure for OSA
13. Requirements of oxygen or bi-level pressure during the CPAP titration PSG (PSG used to determine specifications for CPAP administration)

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)
Men and women aged 50-80 years will be referred from the Healthy Brain Ageing Clinic, Brain & Mind Research Institute and the Sleep Clinic, Woolcock Institute for Medical Research. Once informed consent is obtained, all baseline assessments are complete, and the Trial Coordinator along with a Trial Clinician has assessed eligibility and made the decision to enrol a participant, the Research Officer responsible for randomly allocating participants to treatment will be notified. Treatment allocation will be undertaken in accordance with the randomisation schedule which will be generated prior to trial commencement. The Research Officer, who will not have any involvement in the booking or conduct of assessments, will advise the participant of their allocated treatment group and next steps. The electronic randomisation schedule will be password protected and accessible only to the Research Officer responsible for treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to treatment using a randomly generated number sequence calculated used Research Randomizer (http://www.randomizer.org/) prior to trial commencement. The fully replicable procedure will incorporate permuted blocks of varying lengths and will include stratification by OSA severity, with strata defined by a apnoea-hypopnoea index of < 30 or >= 30. Participants will be allocated to either CPAP Intervention-Control or Control-CPAP Intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is predominantly a pilot study to determine overall effect size to fund larger trials. It is estimated there will be 80% power to determine a medium to large effect size with this sample of 40 participants (and crossover design).
Primary analyses will be undertaken on an intention-to-treat basis. Outcome data will be analysed using repeated measures ANOVA. All analyses will be two-tailed with an alpha of 0.05.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
5/05/2014
Actual
7/04/2014
Date of last participant enrolment
Anticipated
Actual
5/06/2019
Date of last data collection
Anticipated
Actual
4/09/2019
Sample size
Target
40
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289083 0
Charities/Societies/Foundations
Name [1] 289083 0
Alzheimer's Australia
Country [1] 289083 0
Australia
Funding source category [2] 289122 0
Commercial sector/Industry
Name [2] 289122 0
ResMed Ltd
Country [2] 289122 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 287770 0
Other Collaborative groups
Name [1] 287770 0
Woolcock Institute
Address [1] 287770 0
431 Glebe Point Road
Glebe NSW 2037
Country [1] 287770 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290872 0
University of Sydney Human Ethics
Ethics committee address [1] 290872 0
Ethics committee country [1] 290872 0
Australia
Date submitted for ethics approval [1] 290872 0
Approval date [1] 290872 0
21/01/2013
Ethics approval number [1] 290872 0
2012/2877

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

Contacts
Principal investigator
Name 47698 0
Prof Sharon Naismith
Address 47698 0
BRAIN & MIND RESEARCH INSTITUTE
THE UNIVERSITY OF SYDNEY
Level 5 Building F
94 Mallet Street
Camperdown NSW 2050
Country 47698 0
Australia
Phone 47698 0
+61 2 9351 0781
Fax 47698 0
Email 47698 0
[email protected]
Contact person for public queries
Name 47699 0
Nathan Cross
Address 47699 0
Brain & Mind Research Institute
THE UNIVERSITY OF SYDNEY
Level 3, Building M02F
94 Mallett St
Camperdown NSW 2050
Country 47699 0
Australia
Phone 47699 0
+61 2 9351 0762
Fax 47699 0
Email 47699 0
[email protected]
Contact person for scientific queries
Name 47700 0
Zoe Terpening
Address 47700 0
BRAIN & MIND RESEARCH INSTITUTE
THE UNIVERSITY OF SYDNEY
Level 5 Building F
94 Mallet Street
Camperdown NSW 2050
Country 47700 0
Australia
Phone 47700 0
+61 2 9351 0750
Fax 47700 0
Email 47700 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Data will be made available upon request, after publication, with no end date determined
Available to whom?
Data will be made available upon request, after publication and will be determined upon negotiation with researchers who provided a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Secure data transfer and signed data access agreement. The principal Investigator Sharon Naismith can be contacted to obtain the data ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14773Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseContinuous Positive Airway Pressure for Cognition in Sleep Apnea and Mild Cognitive Impairment: A Pilot Randomized Crossover Clinical Trial.2022https://dx.doi.org/10.1164/rccm.202111-2646LE
Dimensions AIImpaired Humoral and Cellular Responses to COVID-19 Vaccine in Heart and Lung Transplant Recipients2022https://doi.org/10.1164/rccm.202109-2026le
N.B. These documents automatically identified may not have been verified by the study sponsor.