Sleep Apnea, ObstructiveNCT02781740
Effects of Suboptimal CPAP Therapy on Symptoms of Obstructive Sleep Apnoea
A study testing Continous Positive Air Pressure Device in people with Sleep Apnea, Obstructive, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Continous Positive Air Pressure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2016to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Pulmonary Division, University Hospital Zurich
Zurich, 8091
About this study
Official title: Effects of Suboptimal Use of 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Continous Positive Air Pressure Device
- Keywords
- Continous Positive Airway Pressure, CPAP, Sham CPAP, CPAP withdrawal, suboptimal CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous Positive Air Pressure DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| CPAP therapy | Active comparator | Continuation of the already established CPAP therapy. Receives: 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. Receives: Device: Continous Positive Air Pressure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epworth Sleepiness Scale (ESS)
Standard, well-established Epworth questionnaire. Score values between 0 and 24 represent severity of daytime sleepiness.
Measured: Change from baseline in ESS after 2 weeks of CPAP or sham-CPAP respectively.
Secondary outcomes (10)
Apnoea-Hypopnoea Index (AHI)
AHI acquired non-invasively by respiratory polygraphy at baseline and after 2 weeks. Measured in events per hour it represents severity of sleep apnoea.
Measured: Change from baseline in AHI after 2 weeks of CPAP or sham-CPAP respectively.
Oxygen Desaturation Index (ODI)
ODI acquired non-invasively by respiratory polygraphy at baseline and after 2 weeks. Measured in events per hour it represents severity of sleep apnoea.
Measured: Change from baseline in ODI after 2 weeks of CPAP or sham-CPAP respectively.
Mean CPAP usage time
Acquired automatically by the CPAP/sham-CPAP devices over the course of 2 weeks. Measured in hours per night it represents treatment adherence.
Measured: Measured at baseline and after 2 weeks of CPAP or sham-CPAP respectively.
Heart rate
Resting heart rate acquired non-invasively during wakefulness following respiratory polygraphies at baseline and after 2 weeks. Measured in beats per minute (bpm).
Measured: Change from baseline in heart rate after 2 weeks of CPAP or sham-CPAP respectively.
Mean blood pressure
Mean resting blood pressure acquired non-invasively during wakefulness following respiratory polygraphies at baseline and after 2 weeks. Measured in mmHg.
Measured: Change from baseline in mean blood pressure after 2 weeks of CPAP or sham-CPAP respectively.
Fatigue Severity Scale (FSS)
Standard, well-established FSS questionnaire. Score values between 7 and 63 represent severity of daytime fatigue.
Measured: Change from baseline in FSS after 2 weeks of CPAP or sham-CPAP respectively.
Quality of life as assessed in Short Form 36 (SF-36)
Standard, well-established 36-item patient-reported survey of patient general health status.
Measured: Change from baseline in SF-36 after 2 weeks of CPAP or sham-CPAP respectively.
Quality of life as assessed in Functional Outcomes of Sleep Questionnaire 10 (FOSQ-10)
FOSQ-10 is a standard, well-established 10-item patient-reported survey of impact of disorders of excessive sleepiness on activities of daily living.
Measured: Change from baseline in FOSQ-10 after 2 weeks of CPAP or sham-CPAP respectively.
Psychomotor vigilance as measured through the Oxford Sleep Resistance test (OSLER).
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.
Measured: Change from baseline in OSLER after 2 weeks of CPAP or sham-CPAP respectively.
Psychomotor vigilance as measured through the Multiple Unprepared Reaction Time Test (MURT)
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.
Measured: Change from baseline in MURT after 2 weeks of CPAP or sham-CPAP respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study start1 Apr 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Malcolm Kohler, Prof. Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781740
- Sponsor's protocol ID
- KEK-ZH-Nr.: 2016-00332
- Other IDs
- 2015-MD-0037, CIV-15-12-014246
- Status last verified
- Dec 2018
- First submitted
- 11 May 2016
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31862764
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Suboptimal Use of CPAP Therapy on Symptoms of Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT02781740
- Acronym / sponsor ID
- KEK-ZH-Nr.: 2016-00332
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Continous Positive Airway Pressure, CPAP, Sham CPAP, CPAP withdrawal, suboptimal CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP therapy | Active comparator | Device: Continous Positive Air Pressure DeviceContinuation of the already established CPAP therapy. |
| Sham CPAP therapy | Sham comparator | Device: Continous Positive Air Pressure DeviceSham-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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continous Positive Air Pressure Device | Device | CPAP therapy, Sham CPAP therapy |
Primary outcome
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.
10 secondary outcomes
Apnoea-Hypopnoea Index (AHI)
Time frame: Change from baseline in AHI after 2 weeks of CPAP or sham-CPAP respectively.
Oxygen Desaturation Index (ODI)
Time frame: Change from baseline in ODI after 2 weeks of CPAP or sham-CPAP respectively.
Mean CPAP usage time
Time frame: Measured at baseline and after 2 weeks of CPAP or sham-CPAP respectively.
Heart rate
Time frame: Change from baseline in heart rate after 2 weeks of CPAP or sham-CPAP respectively.
Mean blood pressure
Time frame: Change from baseline in mean blood pressure after 2 weeks of CPAP or sham-CPAP respectively.
Fatigue Severity Scale (FSS)
Time frame: Change from baseline in FSS after 2 weeks of CPAP or sham-CPAP respectively.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Derived from this study: PubMed 31862764Gaisl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Kohler, Prof. Dr. med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continous Positive Air Pressure Device in people with Sleep Apnea, Obstructive, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epworth Sleepiness Scale (ESS) (time frame: Change from baseline in ESS after 2 weeks of CPAP or sham-CPAP respectively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02781740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.