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

OSA Clinical Trial

— POSTURAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336515
• Other study ID #: 2014142
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: July 27, 2018

Study information

• Verified date: October 2019
• Source: Hospital Universitario Araba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: July 27, 2018
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• OSA
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• 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)

Behavioral:
• Group A-General Recommendation
General recommendation not sleeping in supine position

Locations

Country	Name	City	State
Spain	Hospital Universitario Araba	Gasteiz / Vitoria	Araba

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Universitario Araba	Hospital Arnau de Vilanova, Instituto de Salud Carlos III, Instituto Vasco de Investigación Sanitaria (BIOEF), SIBEL SL

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View Citation

Cartwright RD. Effect of sleep position on sleep apnea severity. Sleep. 1984;7(2):110-4. — View Citation

Durán 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. — View Citation

Durán-Cantolla J, Mar J, de La Torre Muñecas 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. Spanish. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Maintain the quantity and the quality of sleep	To determine the effectiveness of the device for to maintain the quantity and the quality of sleep, measured by polysomnography (PSG).	three month
Secondary	Side effects	To determine the side effects.	three month
Secondary	Reduction of snoring	To determine the effectiveness of the device for the reduction of snoring, measured by polysomnography (PSG).	three month
Secondary	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
Secondary	Blood pressure	Blood pressure measurements: systolic blood pressure and diastolic blood pressure.	three month
Secondary	Anthropometric variables (Body mass index)	Body mass index	three month
Secondary	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