Sleep position device versus continuous positive airway pressure in central sleep apnea

Phase 3

• Conditions: Positional central sleep apnea syndrome; Nervous System Diseases

• Registration Number: ISRCTN36132797
• Lead Sponsor: Martini Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-11
• Last Update Posted: 8 January 2024
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• 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 heart failure (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