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

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ClinicalTrials.gov Identifier: NCT03336515
Recruitment Status : Active, not recruiting
First Posted : November 8, 2017
Last Update Posted : January 8, 2018
Sponsor:
Collaborators:
SIBEL SL
Hospital Arnau de Vilanova
Instituto de Salud Carlos III
Instituto Vasco de Investigación Sanitaria (BIOEF)
Information provided by (Responsible Party):
Joaquin Duran-Cantolla, MD, Hospital Universitario Araba

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).

Condition or disease Intervention/treatment Phase
OSA Device: Group C-Postural device activated Device: Group B-Postural device no activated Behavioral: Group A-General Recommendation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)
Study Start Date : September 2015
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: Intervention



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Side effects [ Time Frame: three month ]
    To determine the side effects.

  4. Reduction of snoring [ Time Frame: three month ]
    To determine the effectiveness of the device for the reduction of snoring, measured by polysomnography (PSG).

  5. 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.

  6. Blood pressure [ Time Frame: three month ]
    Blood pressure measurements: systolic blood pressure and diastolic blood pressure.

  7. Anthropometric variables (Body mass index) [ Time Frame: three month ]
    Body mass index

  8. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ≥ 18 years old with diagnosis of positional OSA by PSG.
  • Apnea-Hypopnea index (AHI) >10
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336515


Locations
Spain
Hospital Universitario Araba
Gasteiz / Vitoria, Araba, Spain, 01009
Sponsors and Collaborators
Hospital Universitario Araba
SIBEL SL
Hospital Arnau de Vilanova
Instituto de Salud Carlos III
Instituto Vasco de Investigación Sanitaria (BIOEF)
Investigators
Principal Investigator: Joaquin Duran-Cantolla, MD Hospital Universitario Araba
Principal Investigator: Jordi Rigau, Ing Sibel SA

Publications:

Responsible Party: Joaquin Duran-Cantolla, MD, Principal Investigator. MD,PhD, Hospital Universitario Araba
ClinicalTrials.gov Identifier: NCT03336515     History of Changes
Other Study ID Numbers: 2014142
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Joaquin Duran-Cantolla, MD, Hospital Universitario Araba:
Positional Obstructive Sleep Apnea
Postural Device
Treatment

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases