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

October 2, 2019 updated by: Joaquin Duran-Cantolla, MD, Hospital Universitario Araba
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Araba
      • Gasteiz / Vitoria, Araba, Spain, 01009
        • Hospital Universitario Araba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A-General Recommendation
General recommendation not sleeping in supine position without the postural device
Behavioral: Group A-General Recommendation
General recommendation not sleeping in supine position
Other Names:
  • Control
Placebo Comparator: Group B-Postural device no activated
General recommendation not sleeping in supine position and the postural device without any activation (placebo)
Device: Group B-Postural device no activated
General recommendation not sleeping in supine position and the postural device without any activation (placebo)
Other Names:
  • Placebo
Experimental: Group C-Postural device activated
General recommendation not sleeping in supine position and the postural device activated (intervention group).
Device: Group C-Postural device activated
General recommendation not sleeping in supine position and the postural device activated (intervention group).
Other Names:
  • Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index (AHI)
Time Frame: three month
The effectiveness of the treatment will be measured by polysomnography (PSG), comparing the results of the basal PSG with the results of the final PSG (3 month), based on the results of the apnea hypopnea index (AHI).
three month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduce the time spent in supine position
Time Frame: three month
To determine the effectiveness of the device for to reduce the time spent in supine position, measured by polysomnography, comparing the results of the basal PSG with the results of the final PSG (3 month).
three month
Maintain the quantity and the quality of sleep
Time Frame: three month
To determine the effectiveness of the device for to maintain the quantity and the quality of sleep, measured by polysomnography (PSG).
three month
Side effects
Time Frame: three month
To determine the side effects.
three month
Reduction of snoring
Time Frame: three month
To determine the effectiveness of the device for the reduction of snoring, measured by polysomnography (PSG).
three month
Epworth Sleepiness Scale
Time Frame: at baseline and at three month of follow-up
The Epworth Sleepiness Scale score (the sum of 8 items score, 0-3) can range from 0 to 24. Scores of 11-24 represent increasing levels of excessive daytime sleepiness.
at baseline and at three month of follow-up
Blood pressure
Time Frame: three month
Blood pressure measurements: systolic blood pressure and diastolic blood pressure.
three month
Anthropometric variables (Body mass index)
Time Frame: three month
Body mass index
three month
Quality of life (EuroQOL test)
Time Frame: at baseline and at three month of follow-up
Evaluate by EuroQOL test, is a standardised measure of health status. Description of the state of health in five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each of wich is defined with three levels of severity, as measured by a Likert scale type(no problems, some problems and many problems or inability to activity).
at baseline and at three month of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Araba

Collaborators

Hospital Arnau de Vilanova
Instituto de Salud Carlos III
SIBEL SL
Instituto Vasco de Investigación Sanitaria (BIOEF)

Investigators

  • Principal Investigator: Joaquin Duran-Cantolla, MD, Hospital Universitario Araba
  • Principal Investigator: Jordi Rigau, Ing, Sibel SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

April 27, 2018

Study Completion (Actual)

July 27, 2018

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

November 3, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014142

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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