Status:
COMPLETED
Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)
Lead Sponsor:
Hospital Universitario Araba
Collaborating Sponsors:
SIBEL SL
Hospital Arnau de Vilanova
Conditions:
OSA
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the study is validity of the effectiveness of a vibrating postural device in reduce the respiratory events (Apnea-Hypopnea Index-AHI) in patients with positional Obstructive Sleep Apn...
Detailed Description
PURPOSE: The objective of the study is validity of the effectiveness of a vibrating postural device in reduce the respiratory events (Apnea-Hypopnea Index-AHI) in patients with positional Obstructive...
Eligibility Criteria
Inclusion
- Men and women ≥ 18 years old with diagnosis of positional OSA by PSG.
- Apnea-Hypopnea index (AHI) ≥ 5
- Apnea-Hypopnea index (AHI) in supine position doubling AHI in not supine position
- Time in supine position ≥ 20% total sleep time.
- Total sleep time at least 180 minutes
- Not received any treatment for OSA in the last four weeks before inclusion at the study (Except hygienic measures)
- Written informed consent signed.
Exclusion
- Important problems of physical mobility
- Body mass index \> 40kg/m²
- Presence of any previously diagnosed sleep disorders (narcolepsy, insomnia...) or difficulty in adopting a standard sleeping position
- Cognitive impairment, professional driver, use dangerous machinery, workers in three shifts, pregnant women or patients with severe disease.
- Patients with severe cardiovascular and/or respiratory comorbidity
- Excessive daytime sleepiness, Epworth scale \>12
- Treatment with psychotropic drugs, central stimulant drugs, antidepressants, consumers of illegal drugs or consume \> 80 grams of ethanol per day.
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2018
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03336515
Start Date
September 1 2015
End Date
July 27 2018
Last Update
October 3 2019
Active Locations (1)
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1
Hospital Universitario Araba
Vitoria-Gasteiz, Araba, Spain, 01009