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NCT Number: NCT02781740

Effects of Suboptimal CPAP Therapy on Symptoms of Obstructive Sleep Apnoea

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threshold effect and so it is unclear whether such patients actually benefit from treatment or whether they could be withdrawn from CPAP, thus substantially reducing health care costs, or encouraged to increase their nightly usage of CPAP.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

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary Division, University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continous Positive Air Pressure Device

Device

Primary outcomes

  1. Epworth Sleepiness Scale (ESS)

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

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

Secondary outcomes

  1. Apnoea-Hypopnoea Index (AHI)

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

    AHI acquired non-invasively by respiratory polygraphy at baseline and after 2 weeks. Measured in events per hour it represents severity of sleep apnoea.

  2. Oxygen Desaturation Index (ODI)

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

    ODI acquired non-invasively by respiratory polygraphy at baseline and after 2 weeks. Measured in events per hour it represents severity of sleep apnoea.

  3. Mean CPAP usage time

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

    Acquired automatically by the CPAP/sham-CPAP devices over the course of 2 weeks. Measured in hours per night it represents treatment adherence.

  4. Heart rate

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

    Resting heart rate acquired non-invasively during wakefulness following respiratory polygraphies at baseline and after 2 weeks. Measured in beats per minute (bpm).

  5. Mean blood pressure

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

    Mean resting blood pressure acquired non-invasively during wakefulness following respiratory polygraphies at baseline and after 2 weeks. Measured in mmHg.

  6. Fatigue Severity Scale (FSS)

    Time frame: Change from baseline in FSS after 2 weeks of CPAP or sham-CPAP respectively.

    Standard, well-established FSS questionnaire. Score values between 7 and 63 represent severity of daytime fatigue.

  7. Quality of life as assessed in Short Form 36 (SF-36)

    Time frame: Change from baseline in SF-36 after 2 weeks of CPAP or sham-CPAP respectively.

    Standard, well-established 36-item patient-reported survey of patient general health status.

  8. Quality of life as assessed in Functional Outcomes of Sleep Questionnaire 10 (FOSQ-10)

    Time frame: Change from baseline in FOSQ-10 after 2 weeks of CPAP or sham-CPAP respectively.

    FOSQ-10 is a standard, well-established 10-item patient-reported survey of impact of disorders of excessive sleepiness on activities of daily living.

  9. Psychomotor vigilance as measured through the Oxford Sleep Resistance test (OSLER).

    Time frame: Change from baseline in OSLER after 2 weeks of CPAP or sham-CPAP respectively.

    OSLER is a standard test consisting of one to three 40-min sessions assessing the patients ability of performing a repetitive task. The OSLER error index measured in events per hour correlates statistically with sleep latency.

  10. Psychomotor vigilance as measured through the Multiple Unprepared Reaction Time Test (MURT)

    Time frame: Change from baseline in MURT after 2 weeks of CPAP or sham-CPAP respectively.

    MURT is a standard test consisting of two 10-min sessions assessing the patient's alertness. The MURT time measured in milliseconds represents the patients reaction time and correlates with sleep latency.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

Effects of Suboptimal Use of CPAP Therapy on Symptoms of Obstructive Sleep Apnoea

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 24, 2016
Registry last updated
Dec 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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