Clinical trial NCT02781740: Effects of Suboptimal CPAP Therapy on Symptoms of Obstructive Sleep Apnoea
Official title: Effects of Suboptimal Use of CPAP Therapy on Symptoms of Obstructive Sleep Apnoea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Continous Positive Airway Pressure
CPAP
Sham CPAP
CPAP withdrawal
suboptimal CPAP
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2016-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder. The most effective treatment for OSA is continuous positive airway pressure (CPAP). CPAP therapy has been shown to significantly reduce subjective sleepiness and blood pressure in patients with symptomatic OSA. Its effectiveness tends to depend on its nightly usage and a commonly held view is that CPAP should be used for at least 4h/night. However, previous studies have estimated that a considerable proportion of CPAP users fail to achieve this. In addition, there is inadequate evidence to support this apparent threshold effect and so it is unclear whether such patients actually benefit from treatment or whether they could be withdrawn from CPAP, thus substantially reducing health care costs, or encouraged to increase their nightly usage of CPAP.

The aim of the proposed project is to study the effect of CPAP withdrawal on subjective sleepiness in OSA patients using CPAP for less than 4h/night on average. We hypothesize that two-week CPAP withdrawal in patients with 3-4h/night use will lead to a return of OSA-related symptoms. This trial will better establish the minimum level of CPAP adherence which could generally be regarded as effective in reducing OSA-related symptoms.


Eligibility criteria: Inclusion Criteria:

* Objectively confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI, ≥4% dips) of ≥15/h and an ESS of \>10.
* Currently ≥15/h oxygen desaturations (≥4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP.
* Eligible patients must have been treated with CPAP for more than 12 months with a mean compliance between 3 and 4h/night. Apnoea-hypopnoea index (AHI) must be less than 10 with treatment (according to CPAP machine download data).

Exclusion Criteria:

* Previous ventilatory failure (awake PaO2\<9.0kPa or arterial PaCO2\>6kPa).
* Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (\>180/110mmHg).
* Previously diagnosed with Cheyne-Stokes breathing.
* Current professional driver.
* Age \< 20 or \> 75 years at trial entry.

Primary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Change from baseline in ESS after 2 weeks of CPAP or sham-CPAP respectively.
Secondary outcomes:
measure: Apnoea-Hypopnoea Index (AHI)
timeFrame: Change from baseline in AHI after 2 weeks of CPAP or sham-CPAP respectively.
measure: Oxygen Desaturation Index (ODI)
timeFrame: Change from baseline in ODI after 2 weeks of CPAP or sham-CPAP respectively.
measure: Mean CPAP usage time
timeFrame: Measured at baseline and after 2 weeks of CPAP or sham-CPAP respectively.
measure: Heart rate
timeFrame: Change from baseline in heart rate after 2 weeks of CPAP or sham-CPAP respectively.
measure: Mean blood pressure
timeFrame: Change from baseline in mean blood pressure after 2 weeks of CPAP or sham-CPAP respectively.
measure: Fatigue Severity Scale (FSS)
timeFrame: Change from baseline in FSS after 2 weeks of CPAP or sham-CPAP respectively.
measure: Quality of life as assessed in Short Form 36 (SF-36)
timeFrame: Change from baseline in SF-36 after 2 weeks of CPAP or sham-CPAP respectively.
measure: Quality of life as assessed in Functional Outcomes of Sleep Questionnaire 10 (FOSQ-10)
timeFrame: Change from baseline in FOSQ-10 after 2 weeks of CPAP or sham-CPAP respectively.
measure: Psychomotor vigilance as measured through the Oxford Sleep Resistance test (OSLER).
timeFrame: Change from baseline in OSLER after 2 weeks of CPAP or sham-CPAP respectively.
measure: Psychomotor vigilance as measured through the Multiple Unprepared Reaction Time Test (MURT)
timeFrame: Change from baseline in MURT after 2 weeks of CPAP or sham-CPAP respectively.
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Pulmonary Division, University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Malcolm Kohler, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaisl T, Rejmer P, Thiel S, Haile SR, Osswald M, Roos M, Bloch KE, Stradling JR, Kohler M. Effects of suboptimal adherence of CPAP therapy on symptoms of obstructive sleep apnoea: a randomised, double-blind, controlled trial. Eur Respir J. 2020 Mar 20;55(3):1901526. doi: 10.1183/13993003.01526-2019. Print 2020 Mar.