Positional Therapy Versus CPAP for Positional OSA

Comparing a Convenient Positional Therapy Device to CPAP for Treatment of Positional Obstructive Sleep Apnea, A Crossover Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes
• Intervention / Treatment: Device: Night Shift positional device; Device: continuous positive airway pressure

Detailed Description

This study aims to compare a convenient positional therapy (PT) device used for 8 weeks to continuous positive airway pressure (CPAP) used for 8 weeks in patients with positional obstructive sleep apnea (OSA) in a crossover randomized controlled trial.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Changi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 21 years and above
2. Epworth sleepiness scale 10 to 16
3. No CPAP treatment or PT treatment for past 6 months

4. A diagnosis of positional OSA based on a full in-laboratory overnight polysomnography with

   1. Total apnea/hypopnea index (AHI) >10 /hour and non-supine AHI < 10/hour
   2. Supine AHI greater than or equal to two times the non-supine AHI
   3. At least 15 minutes of supine and non-supine sleep

Exclusion Criteria:

1. Epworth sleepiness scale ≥17
2. Commercial driving
3. Unable or unwilling to use both treatments (CPAP and PT)
4. Concurrent use of therapy for OSA such as mandibular advancement splints
5. Conditions that preclude the ability to lie in a non-supine position, for example a shoulder injury
6. Uncontrolled severe medical/psychiatric conditions such as severe chronic heart failure, malignancy.
7. Patients with pacemaker
8. Skin sensitivity around the neck and/or open wound around their neck

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Night Shift positional device; Randomized to Night shift positional therapy first for 8 weeks, followed by CPAP for 8 weeks, with a 1 week washout period.	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.
ACTIVE_COMPARATOR: Continuous positive airway pressure; Randomized to CPAP first for 8 weeks, followed by positional therapy for 8 weeks, with a 1 week washout period.	Device: continuous positive airway pressure; Automated adjusting continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epworth Sleepiness Scale ( ESS)	Difference in sleepiness ( PT minus CPAP) measured by the Epworth Sleepiness Scale ( ESS) after 8 weeks of device use	8 weeks after the beginning of each intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Outcomes of Sleep Questionnaire ( FOSQ)	Difference in FOSQ	8 weeks after the beginning of each intervention
36-Item Short Form Survey (SF-36)	Difference in SF-36	8 weeks after the beginning of each intervention
Pittsburgh Sleep Quality Index (PSQI)	Difference in PSQI	8 weeks after the beginning of each intervention
Apnea-hypopnea Index ( AHI, events/hr)	Difference in AHI	8 weeks after the beginning of each intervention
DASS21 questionnaire	Difference in mood symptoms ( DASS21)	8 weeks after the beginning of each intervention
Patient adherence ( hours of device use per night)	Compare patient adherence based on device download information	8 weeks after the beginning of each intervention
Patient preference	patient preference for treatment modality will be assessed via a questionnaire	Upon study completion at week 17
Oxygen desaturation index (3%) and lowest oxygen saturation ( %)	Oxygen indices	8 weeks after the beginning of each intervention

Collaborators and Investigators

• Sponsor: Changi General Hospital

Publications and helpful links

General Publications

• Mok Y, Tan A, Hsu PP, Seow A, Chan YH, Wong HS, Poh Y, Wong KKH. Comparing treatment effects of a convenient vibratory positional device to CPAP in positional OSA: a crossover randomised controlled trial. Thorax. 2020 Apr;75(4):331-337. doi: 10.1136/thoraxjnl-2019-213547. Epub 2020 Jan 2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2017
• Primary Completion (ACTUAL): December 10, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: April 9, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (ACTUAL): April 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 5, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: CPAP; Sleep Apnea Syndromes; Night Shift; Positional sleep apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: OSA_RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes