Positional central sleep apnea syndrome Nervous System Diseases
Conditions
Interventions
This is a single-centre randomised prospective trial between CPAP and sleep position device treatment.
Written patient informed consent will be obtained. Diagnosis at baseline is by polysomnography.
Sponsors
Martini Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total apnea-hypopnea index (AHI) measured using polysomnography at baseline, 3 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total central AI, total central AHI, AHI supine, AHI non-supine, supine central AHI, non-supine central AHI, total sleep time supine, total sleep time non-supine measured using polysomnography outcome parameters which are scored manually by scorers blinded to the treatment arm 2. Sleepiness measured using the Epworth Sleepiness Scale (ESS) at baseline and 3 and 12 months 3. Compliance measured using digital use readings from the Night-Balance sleep position device and CPAP machine at 3 and 12 months follow-up 4. Other study parameters: General baseline measurements: age, sex, weight, height, BMI, active smoking yes/no | — |
Countries
Netherlands
Contacts
Public ContactWouter Jacobs
Outcome results
None listed