NCT03336515

Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Hospital Universitario Araba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Apnea (OSA).

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 Sleep Apnea (OSA). The postural device is a vibratil device of 5x3 cm and a weight of about 30 grams integrating an accelerometer, a vibration and other sensors. The device is placed on the patient's forehead and when the device detects that the patient is in the supine position for 30 seconds or more, it starts a vibration, with increasing intensity, which ceases when the patient moves to lateral. METHODOLOGY: DESIGN: A multicenter, randomized parallel study controlled by placebo. It will include patients with diagnosis of positional OSA in the Sleep Units of the Hospital Universitario Araba and Hospital Arnau de Vilanova de Lleida. These patients will be randomized to three groups: Group A: General recommendation not sleeping in supine position; Group B: General recommendation not sleeping in supine position and the device without any activation (placebo); Group C: General recommendation not sleeping in supine position and the device activated (intervention group). Patients will undergo a basal conventional polysomnography (PSG) and after 12 weeks of treatment. In addition all patients will be visited at 1, 4, 8 and 12 weeks. PRIMARY OUTCOME: Validity of the effectiveness of a vibrating postural device in reduce the respiratory events in patients with positional Obstructive Sleep Apnea . SECONDARY OUTCOMES: To determine the effectiveness of the device for: 1) To reduce the time spent in supine position; 2)To maintain the quantity and the quality of sleep; 3) The side effects ; 4) Reduction of snoring; 5) Cost-effectiveness analysis.

Conditions

• OSA

Interventions

Type	Name	Description
DEVICE	Group C-Postural device activated	General recommendation not sleeping in supine position and the postural device activated (intervention group).
DEVICE	Group B-Postural device no activated	General recommendation not sleeping in supine position and the postural device without any activation (placebo)
BEHAVIORAL	Group A-General Recommendation	General recommendation not sleeping in supine position

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-04-27
• Completion: 2018-07-27
• First posted: 2017-11-08
• Last updated: 2019-10-03

Locations

1 site across 1 country: Spain