Effects of Suboptimal CPAP Therapy on Symptoms of Obstructive Sleep Apnoea

NCT ID: NCT02781740

Last Updated: 2018-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2018-12-01

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threshold effect and so it is unclear whether such patients actually benefit from treatment or whether they could be withdrawn from CPAP, thus substantially reducing health care costs, or encouraged to increase their nightly usage of CPAP.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.

Conditions

Sleep Apnea, Obstructive

Keywords

Continous Positive Airway Pressure; CPAP; Sham CPAP; CPAP withdrawal; suboptimal CPAP

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

CPAP therapy

Continuation of the already established CPAP therapy.

Group Type: ACTIVE_COMPARATOR

Continous Positive Air Pressure Device

Intervention Type: DEVICE

Sham CPAP therapy

Sham-CPAP is achieved by setting the CPAP machine to the lowest pressure, insertion of a flow-restricting connector at the machine outlet, and insertion of six extra holes in the collar of the main tubing at the end of the mask to allow air escape and to prevent rebreathing of CO2.

Group Type: SHAM_COMPARATOR

Continous Positive Air Pressure Device

Intervention Type: DEVICE

Interventions

Continous Positive Air Pressure Device

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malcolm Kohler, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Pulmonary Division, University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 31862764 (View on PubMed)

Other Identifiers

2015-MD-0037

Identifier Type: OTHER

Identifier Source: secondary_id

CIV-15-12-014246

Identifier Type: OTHER

Identifier Source: secondary_id

KEK-ZH-Nr.: 2016-00332

Identifier Type: -

Identifier Source: org_study_id