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

Study Overview
=================
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 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.

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

Conditions
-----------------
OSA

Intervention / Treatment
-----------------
* Device: Group C-Postural device activated
* Device: Group B-Postural device no activated
* Behavioral: Group A-General Recommendation


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index (AHI) | 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 | 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 | 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 | To determine the side effects. | three month | 
| Reduction of snoring | To determine the effectiveness of the device for the reduction of snoring, measured by polysomnography (PSG). | three month | 
| Epworth Sleepiness Scale | 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 | Blood pressure measurements: systolic blood pressure and diastolic blood pressure. | three month | 
| Anthropometric variables (Body mass index) | Body mass index | three month | 
| Quality of life (EuroQOL test) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Positional Obstructive Sleep Apnea, Postural Device, Treatment