Clinical trial NCT03336515: Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)
Official title: Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Keywords: Positional Obstructive Sleep Apnea
Postural Device
Treatment
Lead sponsor: Hospital Universitario Araba
Sponsor class: OTHER
Collaborators: name: SIBEL SL
name: Hospital Arnau de Vilanova
name: Instituto de Salud Carlos III
name: Instituto Vasco de Investigación Sanitaria (BIOEF)
First posted: 2017-11-08
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: three month
Secondary outcomes:
measure: Reduce the time spent in supine position
timeFrame: three month
measure: Maintain the quantity and the quality of sleep
timeFrame: three month
measure: Side effects
timeFrame: three month
measure: Reduction of snoring
timeFrame: three month
measure: Epworth Sleepiness Scale
timeFrame: at baseline and at three month of follow-up
measure: Blood pressure
timeFrame: three month
measure: Anthropometric variables (Body mass index)
timeFrame: three month
measure: Quality of life (EuroQOL test)
timeFrame: at baseline and at three month of follow-up
Other outcomes:
Locations:
city: Gasteiz / Vitoria
country: Spain
facility: Hospital Universitario Araba
state: Araba
Study officials:
affiliation: Hospital Universitario Araba
name: Joaquin Duran-Cantolla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sibel SA
name: Jordi Rigau, Ing
role: PRINCIPAL_INVESTIGATOR
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