Positional Therapy Versus CPAP for Positional OSA

Sleep Apnea Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125512
• Other study ID #: OSA_RCT
• Status: Completed
• Phase: N/A
• Start date: February 27, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: May 2019
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 30, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes

Intervention

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.
• continuous positive airway pressure
Automated adjusting continuous positive airway pressure

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

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