Clinical trial NCT03125512: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Keywords: Sleep Apnea Syndromes
Positional sleep apnea
CPAP
Night Shift
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 8-week randomized crossover trial with a 1 week washout period.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Epworth Sleepiness Scale ( ESS)
timeFrame: 8 weeks after the beginning of each intervention
Secondary outcomes:
measure: Functional Outcomes of Sleep Questionnaire ( FOSQ)
timeFrame: 8 weeks after the beginning of each intervention
measure: 36-Item Short Form Survey (SF-36)
timeFrame: 8 weeks after the beginning of each intervention
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 weeks after the beginning of each intervention
measure: Apnea-hypopnea Index ( AHI, events/hr)
timeFrame: 8 weeks after the beginning of each intervention
measure: DASS21 questionnaire
timeFrame: 8 weeks after the beginning of each intervention
measure: Patient adherence ( hours of device use per night)
timeFrame: 8 weeks after the beginning of each intervention
measure: Patient preference
timeFrame: Upon study completion at week 17
measure: Oxygen desaturation index (3%) and lowest oxygen saturation ( %)
timeFrame: 8 weeks after the beginning of each intervention
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Yingjuan Mok, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.