A Cross Over Case Control Study of a Vibration Positional Device for Treatment of OSA

NCT02613975 | Completed

• 1 other identifier: CREC 2013.689
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Positional therapy is considered as a kind of conservative treatment especially for patients with OSA which varies with body positions, and has been reported to be useful in selected cases especially those with positional OSA. Positional OSA is present when the overall apnea hyponea index (AHI) is \> 5/hr with a supine AHI being more than 2 times of AHI in other positions, in a symptomatic patient. There will be 2 groups of patients in this study. Group 1 consists of patients with positional OSA who refuse CPAP or tolerate CPAP poorly. They will be provided with a vibration device as treatment, which will be worn on the neck during sleep. This device senses the position of the patient during sleep. It will vibrate when the patient lies supine until the patient turns laterally, thus prevents the patient to lie flat during sleep and reduce the severity of OSA. It will be switched on and off for a period of 15 days alternatively with sleep study performed at the end of each period respectively to determine its efficacy in the on and off mode. There will be a wash out period of 1 week in between the on and off period to remove any residual effect. Group 2 consists of patients with positional OSA who are using dental device but response or tolerated poorly. They will use the vibration device with dental device together as dual therapy, to assess the role of combination therapy. The device will be operated in on and off mode with sleep study being performed in a similar manner as in group 1. Informed consent will be signed. Each participant will have 2 sleep studies performed at home, which will be supported technically by technician visiting their home for hook up of necessary equipment.

Conditions

OSA

Outcome Measures

Primary Outcomes (1)

• Reduction of AHI using the positional device

  1 year

Study Arms (2)

on positional device

EXPERIMENTAL

patients who could not tolerate cpap will be provided with positional device for treatment of OSA which will vibrate when patients lie in prone position

Device: positonal device

patients on dental device

EXPERIMENTAL

patients on dental devices but not optimally treated for OSA will be provided positional device for optimization of treatment for OSA, which will vibrate when patients lie in prone position

Device: positonal device

Interventions

positonal device DEVICE

positional device detects prone positional and will vibrate to cause patient to lie laterally

on positional device; patients on dental device

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with position dependent OSA which is defined as supine AHI \>2 times the AHI in other positions, while an overall AHI \>5/hr.
• Patients who cannot tolerate/not using CPAP.
• Patients who are on dental devices but residual AHI is \> 15 and symptomatic.
• Patients consent to study and able to follow the instruction of using positional device and home sleep study device.

You may not qualify if:

• Patients with pregnancy.
• Patients who refuse home sleep studies.
• Patients with parasomnias.
• Patients who cannot follow the instruction of using positional device or home sleep study device.
• Patients who tolerate CPAP well with good treatment outcome.
• Patients on dental device with good symptoms improvement and residual AHI \< 15/hr

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK

Shatin, Hong Kong

Location

Study Officials

• Kin Wang To, MBChB

  Honoary clinical assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

HK (1)