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Positional Therapy Versus CPAP for Positional OSA

Primary Purpose

Sleep Apnea Syndromes

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Night Shift positional device

continuous positive airway pressure

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring Sleep Apnea Syndromes, Positional sleep apnea, CPAP, Night Shift

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

Changi General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Night Shift positional device

Continuous positive airway pressure

Arm Description

Randomized to Night shift positional therapy first for 8 weeks, followed by CPAP for 8 weeks, with a 1 week washout period.

Randomized to CPAP first for 8 weeks, followed by positional therapy for 8 weeks, with a 1 week washout period.

Outcomes

Primary Outcome Measures

Epworth Sleepiness Scale ( ESS)

Difference in sleepiness ( PT minus CPAP) measured by the Epworth Sleepiness Scale ( ESS) after 8 weeks of device use

Secondary Outcome Measures

Functional Outcomes of Sleep Questionnaire ( FOSQ)

Difference in FOSQ

36-Item Short Form Survey (SF-36)

Difference in SF-36

Pittsburgh Sleep Quality Index (PSQI)

Difference in PSQI

Apnea-hypopnea Index ( AHI, events/hr)

Difference in AHI

DASS21 questionnaire

Difference in mood symptoms ( DASS21)

Patient adherence ( hours of device use per night)

Compare patient adherence based on device download information

Patient preference

patient preference for treatment modality will be assessed via a questionnaire

Oxygen desaturation index (3%) and lowest oxygen saturation ( %)

Oxygen indices

Full Information

NCT ID

NCT03125512

First Posted

April 9, 2017

Last Updated

May 5, 2019

Sponsor

Changi General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03125512

Brief Title

Positional Therapy Versus CPAP for Positional OSA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

February 27, 2017 (Actual)

Primary Completion Date

December 10, 2018 (Actual)

Study Completion Date

December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Changi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea Syndromes

Keywords

Sleep Apnea Syndromes, Positional sleep apnea, CPAP, Night Shift

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

8-week randomized crossover trial with a 1 week washout period.

Masking

Outcomes Assessor

Masking Description

Research staff assessing the outcomes of the study, the scoring of the sleep studies, and data analyses will be blinded.

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Night Shift positional device

Arm Type

Experimental

Arm Description

Randomized to Night shift positional therapy first for 8 weeks, followed by CPAP for 8 weeks, with a 1 week washout period.

Arm Title

Continuous positive airway pressure

Arm Type

Active Comparator

Arm Description

Randomized to CPAP first for 8 weeks, followed by positional therapy for 8 weeks, with a 1 week washout period.

Intervention Type

Device

Intervention Name(s)

Night Shift positional device

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

continuous positive airway pressure

Intervention Description

Automated adjusting continuous positive airway pressure

Primary Outcome Measure Information:

Title

Epworth Sleepiness Scale ( ESS)

Description

Difference in sleepiness ( PT minus CPAP) measured by the Epworth Sleepiness Scale ( ESS) after 8 weeks of device use

Time Frame

8 weeks after the beginning of each intervention

Secondary Outcome Measure Information:

Title

Functional Outcomes of Sleep Questionnaire ( FOSQ)

Description

Difference in FOSQ

Time Frame

8 weeks after the beginning of each intervention

Title

36-Item Short Form Survey (SF-36)

Description

Difference in SF-36

Time Frame

8 weeks after the beginning of each intervention

Title

Pittsburgh Sleep Quality Index (PSQI)

Description

Difference in PSQI

Time Frame

8 weeks after the beginning of each intervention

Title

Apnea-hypopnea Index ( AHI, events/hr)

Description

Difference in AHI

Time Frame

8 weeks after the beginning of each intervention

Title

DASS21 questionnaire

Description

Difference in mood symptoms ( DASS21)

Time Frame

8 weeks after the beginning of each intervention

Title

Patient adherence ( hours of device use per night)

Description

Compare patient adherence based on device download information

Time Frame

8 weeks after the beginning of each intervention

Title

Patient preference

Description

patient preference for treatment modality will be assessed via a questionnaire

Time Frame

Upon study completion at week 17

Title

Oxygen desaturation index (3%) and lowest oxygen saturation ( %)

Description

Oxygen indices

Time Frame

8 weeks after the beginning of each intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 21 years and above Epworth sleepiness scale 10 to 16 No CPAP treatment or PT treatment for past 6 months A diagnosis of positional OSA based on a full in-laboratory overnight polysomnography with Total apnea/hypopnea index (AHI) >10 /hour and non-supine AHI < 10/hour Supine AHI greater than or equal to two times the non-supine AHI At least 15 minutes of supine and non-supine sleep Exclusion Criteria: Epworth sleepiness scale ≥17 Commercial driving Unable or unwilling to use both treatments (CPAP and PT) Concurrent use of therapy for OSA such as mandibular advancement splints Conditions that preclude the ability to lie in a non-supine position, for example a shoulder injury Uncontrolled severe medical/psychiatric conditions such as severe chronic heart failure, malignancy. Patients with pacemaker Skin sensitivity around the neck and/or open wound around their neck

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yingjuan Mok, MBBS

Organizational Affiliation

Changi General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changi General Hospital

City

Singapore

ZIP/Postal Code

529889

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

31896735

Citation

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.

Results Reference

derived

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Positional Therapy Versus CPAP for Positional OSA

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