Sleep Position Device Versus Continuous Positive Airway Pressure in Mild to Moderate Central Sleep ApneaA Randomized Trial

Conditions: central positional sleep apnea syndrome

Registration Number: NL-OMON20065

Lead Sponsor: one

Brief Summary: Final results will be published in peer reviewed medical journal

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Patients with central positional sleep apnoea are included in the study.
2. Apnoehypopneuindex = 5 AND = 30.
3. Patient age = 18.

Central sleep apnoea is defined as: AHI = 5 with 50% or more of events occurring without any respiratory effort. And associated with symptoms of either excessive sleepiness or disrupted sleep.

Positional sleep apnoea is defined as having a supine AHI=2x AHI non-supine with =10% and = 90% supine sleep

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
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: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AHI (apnea-hypopneas/hour) at 3 months and at 12 months will be compared to baseline. Succesfull treatment is defined as a reduction in AHI to < 5 events per hour at 3 months. Or either a 50% reduction in baseline AHI or a = 10 decrease in AHI combined with improvement in ESS (= 2 points). The proportion of patients reaching succesfull treatment in both treatment arms will be compared using Fisher’s exact test. Relative risk of succesfull treatment between both treatment arms will be calculated and 95% Confidence interval of the risk difference.<br>

Secondary Outcome Measures

Name	Time	Method
total central AI, total central AHI, AHI supine , AHI non supine, supine central AHI, non-supine central AHI, ESS, total sleep time supine, total sleep time non-supine.Compliance is measured according to digital use readings from Night-Balance sleep position device and CPAP machine, respectively, at 3 and 12 months follow-up.