Status:
UNKNOWN
Cost-effectiveness Analysis and Conditional Response to the Effect of Positional Devices in Obstructive Sleep Apnea
Lead Sponsor:
Hospital Universitario Ramon y Cajal
Collaborating Sponsors:
Philips Healthcare
Conditions:
Obstructive Sleep Apnea of Adult
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objectives of this study are: * To assess the effectiveness and cost-effectiveness of a vibrating positional device (NightBalance, Philips) in the treatment of positional obstructive sleep apnea ...
Detailed Description
Non-inferiority clinical trial open to patients and investigators, multicenter, randomized and controlled to treatment with positional device (PD) and CPAP to evaluate the effectiveness of treatment o...
Eligibility Criteria
Inclusion
- Patients over 18 years of age.
- Signed informed consent.
- Diagnosis of POSA by respiratory polygraphy with the following criteria:
- AHI ≥ 15/h or AHI ≥ 10/h and AHI \<15/h with an Epworth \>10
- AHI ns \<10/h (\<5/h in mild OSA).
- AHI is at least twice the AHI in ns
- Time in supine \>20%.
- Valid recording time\>4h
Exclusion
- Treatment of OSA with CPAP or DAM in the previous month or treatment with surgery for OSA at any time.
- Presence of other sleep disorders or central sleep apnea (central AHI \>50% of total AHI).
- Severe cardiovascular, neuromuscular or pulmonary pathology or chronic home oxygen use.
- Poorly controlled arterial hypertension or refractory arterial hypertension.
- Condition that makes it difficult or impossible to change position during sleep.
- Epworth scale score ≥ 16.
- Professional driver, heavy machinery operator or shift worker.
- Pregnancy.
- Treatment with medication that may interfere with alertness or drowsiness such as: sedative antidepressants, hypnotics, opioids, anticonvulsants or central nervous system stimulants.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT05268471
Start Date
October 1 2022
End Date
December 1 2024
Last Update
August 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Ramón y Cajal, Pneumology Department
Madrid, Spain, 28034