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

Hospital Universitario Araba128 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

128

Conditions

OSA

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Araba

Vitoria-Gasteiz, Araba, Spain

Outcomes

Primary Outcomes

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).

Time frame: three month

Secondary Outcomes

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).

Time frame: 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).

Time frame: three month

Side effects

To determine the side effects.

Time frame: three month

Reduction of snoring

To determine the effectiveness of the device for the reduction of snoring, measured by polysomnography (PSG).

Time frame: 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.

Time frame: at baseline and at three month of follow-up

Blood pressure

Blood pressure measurements: systolic blood pressure and diastolic blood pressure.

Data from ClinicalTrials.gov

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