Effects of Suboptimal CPAP Therapy on Symptoms of Obstructive Sleep Apnoea

NCT02781740 | Completed DMC

• 3 other identifiers: KEK-ZH-Nr.: 2016-003322015-MD-0037CIV-15-12-014246
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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threshold effect and so it is unclear whether such patients actually benefit from treatment or whether they could be withdrawn from CPAP, thus substantially reducing health care costs, or encouraged to increase their nightly usage of CPAP.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

Outcome Measures

Primary Outcomes (1)

• Epworth Sleepiness Scale (ESS)

  Standard, well-established Epworth questionnaire. Score values between 0 and 24 represent severity of daytime sleepiness.

  Change from baseline in ESS after 2 weeks of CPAP or sham-CPAP respectively.

Secondary Outcomes (10)

• Apnoea-Hypopnoea Index (AHI)

  Change from baseline in AHI after 2 weeks of CPAP or sham-CPAP respectively.

• Oxygen Desaturation Index (ODI)

  Change from baseline in ODI after 2 weeks of CPAP or sham-CPAP respectively.

• Mean CPAP usage time

  Measured at baseline and after 2 weeks of CPAP or sham-CPAP respectively.

• Heart rate

  Change from baseline in heart rate after 2 weeks of CPAP or sham-CPAP respectively.

• Mean blood pressure

  Change from baseline in mean blood pressure after 2 weeks of CPAP or sham-CPAP respectively.

Study Arms (2)

CPAP therapy

ACTIVE COMPARATOR

Continuation of the already established CPAP therapy.

Device: Continous Positive Air Pressure Device

Sham CPAP therapy

SHAM COMPARATOR

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.

Device: Continous Positive Air Pressure Device

Interventions

Continous Positive Air Pressure Device DEVICE

CPAP therapy; Sham CPAP therapy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Pulmonary Division, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 31862764 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Malcolm Kohler, Prof. Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 24, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 14, 2018

Record last verified: 2018-12

Locations

CH (1)