se of the Z-cushion in patients with positional Obstructive Sleep Apnea Syndrome: A randomized controlled trial

Completed

Conditions: Disturbed breathing
Obstructive Sleep Apnea
10046304

Registration Number: NL-OMON36124

Lead Sponsor: Gelre Ziekenhuizen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 44

Inclusion Criteria

18 years or older
Ability to understand and read Dutch
Diagnosis of symptomatic mild or moderate OSAS (5 < AHI < 30)
Diagnosis positional OSAS (2*AHInonsupine <= AHIsupine)

Exclusion Criteria

Central sleep apnea syndrome / Cheyne-Stokes respiration
Signs of severe nasal obstruction
Major facial or pharyngeal anatomic abnormalities likely to require surgery
Night or rotating shift work
Severe chronic heart failure
Known history of a known cause of daytime sleepiness and severe sleep disruption (e.g. insomnia, PLMS, narcolepsy)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Assessing the efficacy in AHI reduction using the Z-cushion compared to delay<br /><br>of treatment in patients with mild and moderate positional OSAS. AHI will be<br /><br>assessed by PSG.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Assessing the efficacy with regard to<br /><br>• sleepiness<br /><br>• reducing the sleep time in supine posture<br /><br>• reducing the number of O2 saturation dips<br /><br>using the Z-cushion compared to delay of treatment in patients with mild and<br /><br>moderate positional OSAS.<br /><br>Sleepiness will be assessed by the Epworth Sleepiness Scale. (M. W. Johns,<br /><br>1991; 1994)<br /><br>Sleep time in supine posture and O2 saturation dips will be assessed by PSG.</p><br>