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Positional Therapy Versus CPAP for Positional OSA

NCT03125512 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-05-07

No results posted yet for this study

Summary

This is a crossover randomized controlled trial comparing a convenient positional therapy (PT) device to continuous positive airway pressure (CPAP) in the treatment of positional obstructive sleep apnea (OSA).

Conditions

  • Sleep Apnea Syndromes

Interventions

DEVICE

Night Shift positional device

Night Shift is a small, positional therapy device that is worn at the back of the neck using a latex free silicone rubber strap. The strap is adjustable and is secured with a magnetic clasp. When a supine position is detected, the device vibrates with increasing intensity till the subject changes to a non-supine position.

DEVICE

continuous positive airway pressure

Automated adjusting continuous positive airway pressure

Sponsors & Collaborators

  • Changi General Hospital

    lead OTHER

Principal Investigators

  • Yingjuan Mok, MBBS · Changi General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-27
Primary Completion
2018-12-10
Completion
2018-12-30
FDA Device
Yes

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03125512 on ClinicalTrials.gov