Validity of a Vibrating Postural Device for the Treatment of Positional Obstructive Sleep Apnea (Postural)
NCT ID: NCT03336515
Last Updated: 2019-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2015-09-01
2018-07-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A-General Recommendation
General recommendation not sleeping in supine position without the postural device
Group A-General Recommendation
General recommendation not sleeping in supine position
Group B-Postural device no activated
General recommendation not sleeping in supine position and the postural device without any activation (placebo)
Group B-Postural device no activated
General recommendation not sleeping in supine position and the postural device without any activation (placebo)
Group C-Postural device activated
General recommendation not sleeping in supine position and the postural device activated (intervention group).
Group C-Postural device activated
General recommendation not sleeping in supine position and the postural device activated (intervention group).
Interventions
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Group C-Postural device activated
General recommendation not sleeping in supine position and the postural device activated (intervention group).
Group B-Postural device no activated
General recommendation not sleeping in supine position and the postural device without any activation (placebo)
Group A-General Recommendation
General recommendation not sleeping in supine position
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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SIBEL SL
UNKNOWN
Hospital Arnau de Vilanova
OTHER
Instituto de Salud Carlos III
OTHER_GOV
Instituto Vasco de Investigación Sanitaria (BIOEF)
UNKNOWN
Hospital Universitario Araba
OTHER
Responsible Party
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Joaquin Duran-Cantolla, MD
Principal Investigator. MD,PhD
Principal Investigators
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Joaquin Duran-Cantolla, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Araba
Jordi Rigau, Ing
Role: PRINCIPAL_INVESTIGATOR
Sibel SA
Locations
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Hospital Universitario Araba
Vitoria-Gasteiz, Araba, Spain
Countries
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References
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Duran J, Esnaola S, Rubio R, Iztueta A. Obstructive sleep apnea-hypopnea and related clinical features in a population-based sample of subjects aged 30 to 70 yr. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):685-9. doi: 10.1164/ajrccm.163.3.2005065.
Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
Duran-Cantolla J, Mar J, de La Torre Munecas G, Rubio Aramendi R, Guerra L. [The availability in Spanish public hospitals of resources for diagnosing and treating sleep apnea-hypopnea syndrome]. Arch Bronconeumol. 2004 Jun;40(6):259-67. doi: 10.1016/s1579-2129(06)70096-9. Spanish.
Cartwright RD. Effect of sleep position on sleep apnea severity. Sleep. 1984;7(2):110-4. doi: 10.1093/sleep/7.2.110.
Oksenberg A, Silverberg DS, Arons E, Radwan H. Positional vs nonpositional obstructive sleep apnea patients: anthropomorphic, nocturnal polysomnographic, and multiple sleep latency test data. Chest. 1997 Sep;112(3):629-39. doi: 10.1378/chest.112.3.629.
Cartwright RD, Lloyd S, Lilie J, Kravitz H. Sleep position training as treatment for sleep apnea syndrome: a preliminary study. Sleep. 1985;8(2):87-94. doi: 10.1093/sleep/8.2.87.
Jokic R, Klimaszewski A, Crossley M, Sridhar G, Fitzpatrick MF. Positional treatment vs continuous positive airway pressure in patients with positional obstructive sleep apnea syndrome. Chest. 1999 Mar;115(3):771-81. doi: 10.1378/chest.115.3.771.
van Maanen JP, Richard W, Van Kesteren ER, Ravesloot MJ, Laman DM, Hilgevoord AA, de Vries N. Evaluation of a new simple treatment for positional sleep apnoea patients. J Sleep Res. 2012 Jun;21(3):322-9. doi: 10.1111/j.1365-2869.2011.00974.x. Epub 2011 Oct 22.
Ravesloot MJ, van Maanen JP, Dun L, de Vries N. The undervalued potential of positional therapy in position-dependent snoring and obstructive sleep apnea-a review of the literature. Sleep Breath. 2013 Mar;17(1):39-49. doi: 10.1007/s11325-012-0683-5. Epub 2012 Mar 24.
Hidalgo-Armas L, Ingles S, Vaca R, Cordero-Guevara J, Duran-Carro J, Ullate J, Rigau J, Duran-Cantolla J; Spanish Sleep Network. Patient compliance and satisfaction with a new forehead device for positional obstructive sleep apnoea treatment: a post hoc analysis of a randomised controlled trial. BMJ Open Respir Res. 2023 Jun;10(1):e001503. doi: 10.1136/bmjresp-2022-001503.
Hidalgo Armas L, Ingles S, Vaca R, Cordero-Guevara J, Duran Carro J, Ullate J, Barbe F, Duran-Cantolla J; Spanish Sleep Network. New forehead device in positional obstructive sleep apnoea: a randomised clinical trial. Thorax. 2021 Sep;76(9):930-938. doi: 10.1136/thoraxjnl-2020-216167. Epub 2021 Apr 22.
Other Identifiers
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2014142
Identifier Type: -
Identifier Source: org_study_id
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