Sleep position device versus continuous positive airway pressure in mild to moderate central sleep apnea A randomized trial.

Conditions: centraal slaap apneu
central sleep apnea

Registration Number: NL-OMON49557

Lead Sponsor: Martini Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

1. Patients with central positional sleep apnoea are included in the study.
2. Apnoehypopneuindex >= 5 AND <= 30.
3. Patient age >= 18.

Exclusion Criteria

1. chronic respiratory insufficiency (paCO2 > 6kPA)
2. BMI >= 30
3. Left sided valvular heart disease > mild
4. Patients with symptomatic heartfailure (AHA stadium C)
5. Night or rotating shift work
6. Active psychiatric disease
7. Seizure disorder
8. Medication use for sleeping disorders
9. Previous treatment with CPAP or sleep position device
10. Simultaneous other OSAS treatments
11. Pregnancy
12. Coexistent non-respiratory sleep disorders (e.g. insomnia, periodic limb
movement disorder, narcolepsy) that would influence functional sleep assessment

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters<br /><br><br /><br>AHI at 3 months and at 12 months will be compared to baseline using students<br /><br>t-test. Succesfull treatment is defined as a reduction in AHI to < 5 events<br /><br>per hour at 3 months. Or either a 50% reduction in baseline AHI or a >= 10<br /><br>decrease in AHI combined with improvement in ESS (>= 2 points) .20,21 The<br /><br>proportion of patients reaching succesfull treatment in both treatment arms<br /><br>will be compared using Chi square test. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameter(s)<br /><br>total central AI, total central AHI, AHI supine , AHI non supine, supine<br /><br>central AHI, non-supine central AHI, ESS, total sleep time supine, total sleep<br /><br>time non-supine will respectively be compared to baseline at resepectively 3<br /><br>months and 12 months using student t-test.<br /><br><br /><br>Other study parameters<br /><br>General baseline measurements: age, sex, weight, height, BMI, active<br /><br>smoking yes/no will be compared between treatment arms using student t-test<br /><br>for continuous parameters and Fisher's Exact test for categorical variables.</p><br>