Effects of Suboptimal CPAP Therapy on Symptoms of Obstructive Sleep Apnoea

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781740
• Other study ID #: KEK-ZH-Nr.: 2016-00332
• Secondary ID: 2015-MD-0037CIV-
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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threshold effect and so it is unclear whether such patients actually benefit from treatment or whether they could be withdrawn from CPAP, thus substantially reducing health care costs, or encouraged to increase their nightly usage of CPAP.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continous Positive Air Pressure Device

Locations

Country	Name	City	State
Switzerland	Pulmonary Division, University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Change from baseline in AHI after 2 weeks of CPAP or sham-CPAP respectively.
Secondary	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.	Change from baseline in ODI after 2 weeks of CPAP or sham-CPAP respectively.
Secondary	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 at baseline and after 2 weeks of CPAP or sham-CPAP respectively.
Secondary	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).	Change from baseline in heart rate after 2 weeks of CPAP or sham-CPAP respectively.
Secondary	Mean blood pressure	Mean resting blood pressure acquired non-invasively during wakefulness following respiratory polygraphies at baseline and after 2 weeks. Measured in mmHg.	Change from baseline in mean blood pressure after 2 weeks of CPAP or sham-CPAP respectively.
Secondary	Fatigue Severity Scale (FSS)	Standard, well-established FSS questionnaire. Score values between 7 and 63 represent severity of daytime fatigue.	Change from baseline in FSS after 2 weeks of CPAP or sham-CPAP respectively.
Secondary	Quality of life as assessed in Short Form 36 (SF-36)	Standard, well-established 36-item patient-reported survey of patient general health status.	Change from baseline in SF-36 after 2 weeks of CPAP or sham-CPAP respectively.
Secondary	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.	Change from baseline in FOSQ-10 after 2 weeks of CPAP or sham-CPAP respectively.
Secondary	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.	Change from baseline in OSLER after 2 weeks of CPAP or sham-CPAP respectively.
Secondary	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.	Change from baseline in MURT after 2 weeks of CPAP or sham-CPAP respectively.