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| Name | Class |
|---|---|
| SIBEL SL | UNKNOWN |
| Hospital Arnau de Vilanova | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
| Instituto Vasco de Investigación Sanitaria (BIOEF) |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A-General Recommendation | Other | General recommendation not sleeping in supine position without the postural device |
|
| Group B-Postural device no activated | Placebo Comparator | General recommendation not sleeping in supine position and the postural device without any activation (placebo) |
|
| Group C-Postural device activated | Experimental | General recommendation not sleeping in supine position and the postural device activated (intervention group). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group C-Postural device activated | Device | General recommendation not sleeping in supine position and the postural device activated (intervention group). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | three month |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | three month |
| Maintain the quantity and the quality of sleep |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joaquin Duran-Cantolla, MD | Hospital Universitario Araba | Principal Investigator |
| Jordi Rigau, Ing | Sibel SA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Araba | Vitoria-Gasteiz | Araba | 01009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11254524 | Background | 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. | |
| 8464434 | Background | 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. |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| UNKNOWN |
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|
| Group B-Postural device no activated | Device | General recommendation not sleeping in supine position and the postural device without any activation (placebo) |
|
|
| Group A-General Recommendation | Behavioral | General recommendation not sleeping in supine position |
|
|
To determine the effectiveness of the device for to maintain the quantity and the quality of sleep, measured by polysomnography (PSG). |
| three month |
| Side effects | To determine the side effects. | three month |
| Reduction of snoring | To determine the effectiveness of the device for the reduction of snoring, measured by polysomnography (PSG). | 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. | at baseline and at three month of follow-up |
| Blood pressure | Blood pressure measurements: systolic blood pressure and diastolic blood pressure. | three month |
| Anthropometric variables (Body mass index) | Body mass index | three month |
| Quality of life (EuroQOL test) | 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). | at baseline and at three month of follow-up |
| 15161592 | Background | 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. |
| 6740055 | Background | Cartwright RD. Effect of sleep position on sleep apnea severity. Sleep. 1984;7(2):110-4. doi: 10.1093/sleep/7.2.110. |
| 9315794 | Background | 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. |
| 4012159 | Background | 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. |
| 10084491 | Background | 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. |
| 22017727 | Background | 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. |
| 22441662 | Background | 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. |
| 37349132 | Derived | 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. |
| 33888576 | Derived | 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. |