Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000576921
Ethics application status
Approved
Date submitted
22/04/2020
Date registered
18/05/2020
Date last updated
18/05/2020
Date data sharing statement initially provided
18/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rapid eye movement (REM) related obstructive sleep apnoea (OSA) and continuous positive airway pressure (CPAP) treatment
Scientific title
Clinical outcomes in patients with REM-related obstructive sleep apnoea (using revised diagnostic criteria) treated with continuous positive airway pressure therapy
Secondary ID [1] 301058 0
None
Universal Trial Number (UTN)
Trial acronym
REM OSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep apnoea 317113 0
Condition category
Condition code
Respiratory 315276 315276 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Continuous positive airway pressure (CPAP) treatment: a CPAP titration study undertaken at Baseline to prevent snoring and return obstructive events to the normal range (standard laboratory protocol). The CPAP titration study will take place in the Sleep Laboratory at Westmead Hospital. Anthropometric data will also be collected including age, gender, height, weight, BMI, blood pressure and neck circumference. Psychomotor Vigilance Test will be performed prior to sleep and repeated within 30 minutes of wakening. The CPAP equipment will be given to the participant on the morning of CPAP titration visit (Baseline visit) to take home and commence therapy. The study coordinator will contact the participants via telephone on a monthly basis to monitor CPAP compliance. CPAP treatment period will run for 12 months with loan mask and CPAP machine provided by Sleep Laboratory from loan pool.

2. Questionnaires and tests will be administered at 1, 3, 6 and 12 months and include Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), depression anxiety and stress score (DASS-21), and Psychomotor Vigilance Test (PVT – test of neuropsychological function). Anthropometric data (weight, BMI, blood pressure and neck circumference), CPAP compliance and adverse events will be reviewed and collected. The participant will attend Westmead Hospital for each visit and the study coordinator will administer the interventions described above.
Intervention code [1] 317405 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323572 0
To evaluate the effect of CPAP over one year on sleepiness assessed using ESS in adults with REM related obstructive sleep apnoea (using new diagnostic PSG criteria)
Timepoint [1] 323572 0
Months 1, 3, 6, and 12 (primary endpoint) post commencement of intervention
Secondary outcome [1] 382250 0
Quality of life, assessed using FOSQ questionnaire
Timepoint [1] 382250 0
Months 1, 3, 6, and 12
Secondary outcome [2] 382610 0
Mood, assessed using DASS-21 questionnaire
Timepoint [2] 382610 0
Months 1, 3, 6 and 12
Secondary outcome [3] 382611 0
Vigilance, assessed using PVT
Timepoint [3] 382611 0
Baseline, months 1, 3, 6 and 12
Secondary outcome [4] 382612 0
Blood pressure using an automatic sphygmomanometer
Timepoint [4] 382612 0
Baseline, months 1, 3, 6 and 12
Secondary outcome [5] 382613 0
CPAP compliance by reviewing the data saved on the SD cards in the CPAP machine
Timepoint [5] 382613 0
Months 1, 3, 6 and 12

Eligibility
Key inclusion criteria
1. Adult patients (greater than 18 years) presenting to the Westmead Sleep Service for investigation of Sleep disordered breathing.

2. Baseline PSG demonstrating the following: REM AHI of greater than or equal to 15 events/hour; an AHI during NREM sleep of less than 5 events/hour; and at least 30 minutes of REM sleep on the diagnostic PSG study night.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unstable cardiac disease
2. Unstable neurologic disease
3. Previous stroke
4. Inability to tolerate nasal CPAP therapy
5. Depression or significant psychiatric disorder affecting sleep.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will include unpaired t-tests or Mann-Whitney tests for continuous variables, and Fisher’s exact test for categorical variables Linear mixed effects models (LME) will be used to investigate the joint effects of time (5-level factor: baseline, months 1, 3, 6 and 12) and average CPAP adherence (2-level factor: less than 4 versus greater than or equal to 4 hours/night) on our continuous outcomes of interest (ESS, BP, PVT, FOSQ and DASS-21). Univariable logistic regression analysis of baseline characteristics of the participants will be performed to identify predictors of CPAP adherence greater than or equal to 4 hours/night.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/06/2016
Date of last participant enrolment
Anticipated
Actual
26/08/2018
Date of last data collection
Anticipated
Actual
26/08/2019
Sample size
Target
30
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16524 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 30080 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 305500 0
Hospital
Name [1] 305500 0
Westmead Hospital
Country [1] 305500 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Cnr Hawkesbury and Darcy Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 305943 0
None
Name [1] 305943 0
Address [1] 305943 0
Country [1] 305943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305812 0
Western Sydney Local Health District HREC
Ethics committee address [1] 305812 0
Ethics committee country [1] 305812 0
Australia
Date submitted for ethics approval [1] 305812 0
17/09/2014
Approval date [1] 305812 0
09/03/2015
Ethics approval number [1] 305812 0
HREC/14/WMEAD/383 (4113)

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

Contacts
Principal investigator
Name 101682 0
Prof John Wheatley
Address 101682 0
Westmead Hospital
Department of Respiratory and Sleep Medicine
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145
Country 101682 0
Australia
Phone 101682 0
+61 2 8890 6797
Fax 101682 0
+61 2 8890 7286
Email 101682 0
[email protected]
Contact person for public queries
Name 101683 0
John Wheatley
Address 101683 0
Westmead Hospital
Department of Respiratory and Sleep Medicine
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145
Country 101683 0
Australia
Phone 101683 0
+61 2 8890 6797
Fax 101683 0
+61 2 8890 7286
Email 101683 0
[email protected]
Contact person for scientific queries
Name 101684 0
John Wheatley
Address 101684 0
Westmead Hospital
Department of Respiratory and Sleep Medicine
Cnr Hawkesbury and Darcy Roads
Westmead NSW 2145
Country 101684 0
Australia
Phone 101684 0
+61 2 8890 6797
Fax 101684 0
+61 2 8890 7286
Email 101684 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseCPAP treatment in REM-related obstructive sleep apnea: a distinct clinical phenotype of sleep disordered breathing.2021https://dx.doi.org/10.1007/s11325-021-02300-8
N.B. These documents automatically identified may not have been verified by the study sponsor.