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

Hospital Universitario Araba

Status: Completed

Conditions: OSA

Treatments: Behavioral: Group A-General Recommendation; Device: Group C-Postural device activated; Device: Group B-Postural device no activated

Study type: Interventional

Funder types: Other

Identifiers

NCT03336515

2014142

Details and patient eligibility

About

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).

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 3 patient groups, including a placebo group

Group A-General Recommendation

Other group

Description:

General recommendation not sleeping in supine position without the postural device

Treatment:

Behavioral: Group A-General Recommendation

Group B-Postural device no activated

Placebo Comparator group

Description:

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

Treatment:

Device: Group B-Postural device no activated

Group C-Postural device activated

Experimental group

Description:

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

Treatment:

Device: Group C-Postural device activated