Positional Therapy Versus CPAP for Positional OSA
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ClinicalTrials.gov Identifier: NCT03125512 |
Recruitment Status :
Completed
First Posted : April 24, 2017
Last Update Posted : May 7, 2019
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Condition or disease | Intervention/treatment | Phase |
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Sleep Apnea Syndromes | Device: Night Shift positional device Device: continuous positive airway pressure | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | 8-week randomized crossover trial with a 1 week washout period. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Research staff assessing the outcomes of the study, the scoring of the sleep studies, and data analyses will be blinded. |
Primary Purpose: | Treatment |
Official Title: | Comparing a Convenient Positional Therapy Device to CPAP for Treatment of Positional Obstructive Sleep Apnea, A Crossover Randomized Controlled Trial |
Actual Study Start Date : | February 27, 2017 |
Actual Primary Completion Date : | December 10, 2018 |
Actual Study Completion Date : | December 30, 2018 |

Arm | Intervention/treatment |
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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.
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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.
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Device: continuous positive airway pressure
Automated adjusting continuous positive airway pressure |
- Epworth Sleepiness Scale ( ESS) [ Time Frame: 8 weeks after the beginning of each intervention ]Difference in sleepiness ( PT minus CPAP) measured by the Epworth Sleepiness Scale ( ESS) after 8 weeks of device use
- Functional Outcomes of Sleep Questionnaire ( FOSQ) [ Time Frame: 8 weeks after the beginning of each intervention ]Difference in FOSQ
- 36-Item Short Form Survey (SF-36) [ Time Frame: 8 weeks after the beginning of each intervention ]Difference in SF-36
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 weeks after the beginning of each intervention ]Difference in PSQI
- Apnea-hypopnea Index ( AHI, events/hr) [ Time Frame: 8 weeks after the beginning of each intervention ]Difference in AHI
- DASS21 questionnaire [ Time Frame: 8 weeks after the beginning of each intervention ]Difference in mood symptoms ( DASS21)
- Patient adherence ( hours of device use per night) [ Time Frame: 8 weeks after the beginning of each intervention ]Compare patient adherence based on device download information
- Patient preference [ Time Frame: Upon study completion at week 17 ]patient preference for treatment modality will be assessed via a questionnaire
- Oxygen desaturation index (3%) and lowest oxygen saturation ( %) [ Time Frame: 8 weeks after the beginning of each intervention ]Oxygen indices

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Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 21 years and above
- Epworth sleepiness scale 10 to 16
- No CPAP treatment or PT treatment for past 6 months
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125512
Singapore | |
Changi General Hospital | |
Singapore, Singapore, 529889 |
Principal Investigator: | Yingjuan Mok, MBBS | Changi General Hospital |
Responsible Party: | Changi General Hospital |
ClinicalTrials.gov Identifier: | NCT03125512 |
Other Study ID Numbers: |
OSA_RCT |
First Posted: | April 24, 2017 Key Record Dates |
Last Update Posted: | May 7, 2019 |
Last Verified: | May 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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 |
Sleep Apnea Syndromes Positional sleep apnea CPAP Night Shift |
Apnea Sleep Apnea Syndromes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |