No registrations found.
ID
Source
Brief title
Health condition
central positional sleep apnea syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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.
Background summary
Objective: To perform a randomized prospective trial comparing long-term outcomes in CPAP versus SPD (night balance) in central positional apnea patients.
Study design: A single-centre randomised prospective trial between CPAP and sleep position device treatment. Randomisation was stratified according to BMI and smoking. Physician and patients are not blinded to the treatment arms. Written patient informed consent is obtained. Diagnosis at baseline is by polysomnography. Eligible patients are randomized to either standard CPAP therapy or SPD treatment.
Epworth Sleepiness Scale (ESS) is measured at baseline and subsequently under treatment at 3 and 12 months. Polysomnography for AHI measurement is repeated under treatment at 3 and 12 months.
Study population: All patients with central positional sleep apnoea, with an AHI ≥ 5 and ≤ 30, are included in the study. 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.
Intervention (if applicable): Patient informed consent is obtained. Participants are assigned to either sleep position device (Night-Balance, Night Balance b.v., The Hague, The Netherlands) or CPAP (standard of care arm).
Study objective
sleep position device is an effective treatment alternative in central positional sleep apnea syndrome
Study design
MEC approval expected within 3 months. First patient randomized expected within 6 months. Study completion expected within 3 years. no interim analysis planned.
Intervention
Participants are assigned to either sleep position device (Night-Balance, Philips, The Netherlands) or CPAP (standard of care arm).
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8397 |
| CCMO | NL70711.099.19 |
| OMON | NL-OMON49557 |