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

NCT03336515 | Completed DMC

• 1 other identifier: 2014142
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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).

Conditions

OSA

Keywords

Positional Obstructive Sleep Apnea; Postural Device; Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Reduce the time spent in supine position

  three month

• Maintain the quantity and the quality of sleep

  three month

• Side effects

  three month

• Reduction of snoring

  three month

• Epworth Sleepiness Scale

  at baseline and at three month of follow-up

Study Arms (3)

Group A-General Recommendation

OTHER

General recommendation not sleeping in supine position without the postural device

Behavioral: Group A-General Recommendation

Group B-Postural device no activated

PLACEBO COMPARATOR

General recommendation not sleeping in supine position and the postural device without any activation (placebo)

Device: Group B-Postural device no activated

Group C-Postural device activated

EXPERIMENTAL

General recommendation not sleeping in supine position and the postural device activated (intervention group).

Device: Group C-Postural device activated

Interventions

Group C-Postural device activated DEVICE

General recommendation not sleeping in supine position and the postural device activated (intervention group).

Also known as: Intervention

Group C-Postural device activated

Group B-Postural device no activated DEVICE

General recommendation not sleeping in supine position and the postural device without any activation (placebo)

Also known as: Placebo

Group B-Postural device no activated

Group A-General Recommendation BEHAVIORAL

General recommendation not sleeping in supine position

Also known as: Control

Group A-General Recommendation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Written informed consent signed.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Araba: lead
• SIBEL SL: collaborator
• Hospital Arnau de Vilanova: collaborator
• Instituto de Salud Carlos III: collaborator
• Instituto Vasco de Investigación Sanitaria (BIOEF): collaborator

Study Sites (1)

Hospital Universitario Araba

Vitoria-Gasteiz, Araba, 01009, Spain

Location

Related Publications (11)

• 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.

  PMID: 11254524 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.

  PMID: 8464434 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.

  PMID: 15161592 BACKGROUND

• Cartwright RD. Effect of sleep position on sleep apnea severity. Sleep. 1984;7(2):110-4. doi: 10.1093/sleep/7.2.110.

  PMID: 6740055 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.

  PMID: 9315794 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.

  PMID: 4012159 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.

  PMID: 10084491 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.

  PMID: 22017727 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.

  PMID: 22441662 BACKGROUND

• 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.

  PMID: 37349132 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.

  PMID: 33888576 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Joaquin Duran-Cantolla, MD

  Hospital Universitario Araba

  PRINCIPAL INVESTIGATOR

• Jordi Rigau, Ing

  Sibel SA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. MD,PhD

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: November 8, 2017
• Study Start: September 1, 2015
• Primary Completion: April 27, 2018
• Study Completion: July 27, 2018
• Last Updated: October 3, 2019

Record last verified: 2019-10

Locations

ES (1)