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Rapid eye movement (REM) related obstructive sleep apnoea (OSA) and continuous positive airway pressure (CPAP) treatment

Clinical outcomes in patients with REM-related obstructive sleep apnoea (using revised diagnostic criteria) treated with continuous positive airway pressure therapy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000576921
Acronym
REM OSA
Enrollment
31
Registered
2020-05-18
Start date
2016-06-22
Completion date
2018-08-26
Last updated
2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study evaluates the impact of CPAP treatment over 1 year on clinical outcomes in patients with REM-related obstructive sleep apnoea.

Interventions

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

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.

Sponsors

Westmead Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 24, 2026