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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Night Shift positional device | Experimental | Randomized to Night shift positional therapy first for 8 weeks, followed by CPAP for 8 weeks, with a 1 week washout period. |
|
| Continuous positive airway pressure | Active Comparator | Randomized to CPAP first for 8 weeks, followed by positional therapy for 8 weeks, with a 1 week washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Night Shift positional device | 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. |
| 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 |
| 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 |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingjuan Mok, MBBS | Changi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Singapore | 529889 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31896735 | Derived | 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. |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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8-week randomized crossover trial with a 1 week washout period.
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Research staff assessing the outcomes of the study, the scoring of the sleep studies, and data analyses will be blinded.
|
| continuous positive airway pressure | Device | Automated adjusting continuous positive airway pressure |
|
| 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 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |