CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 128 enrolled
Drug / intervention
Group C-Postural device activated +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03336515
NCT03336515N/ACompleted
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Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)

Hospital Universitario Araba·interventional·Posted Nov 8, 2017·Updated Oct 3, 2019

In Brief

A clinical study evaluating Group C-Postural device activated, Group B-Postural device no activated, and 1 other intervention for OSA. Completed, enrolled 128 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOSA
CountriesSpain
CollaboratorsSIBEL SL, Hospital Arnau de Vilanova, Instituto de Salud Carlos III, Instituto Vasco de Investigación Sanitaria (BIOEF)

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 8, 2017
Enrollment StartSep 1, 2015
Primary CompletionApr 27, 2018
Study CompletionJul 27, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.7 years ago

Interventions

Group C-Postural device activateddevice

General recommendation not sleeping in supine position and the postural device activated (intervention group).

Group B-Postural device no activateddevice

General recommendation not sleeping in supine position and the postural device without any activation (placebo)

Group A-General Recommendationbehavioral

General recommendation not sleeping in supine position