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

NCT03336515 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2019-10-03

No results posted yet for this study

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).

Conditions

  • OSA

Interventions

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

Sponsors & Collaborators

  • SIBEL SL

    collaborator UNKNOWN

  • Hospital Arnau de Vilanova

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Instituto Vasco de Investigación Sanitaria (BIOEF)

    collaborator UNKNOWN

  • Hospital Universitario Araba

    lead OTHER

Principal Investigators

  • Joaquin Duran-Cantolla, MD · Hospital Universitario Araba

  • Jordi Rigau, Ing · Sibel SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2018-04-27
Completion
2018-07-27

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03336515 on ClinicalTrials.gov