Positional Therapy Versus CPAP for Positional OSA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-27

Study Completion Date

2018-12-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Sleep Apnea Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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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.

Group Type EXPERIMENTAL

Night Shift positional device

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

continuous positive airway pressure

Intervention Type DEVICE

Automated adjusting continuous positive airway pressure

Interventions

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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.

Intervention Type DEVICE

continuous positive airway pressure

Automated adjusting continuous positive airway pressure

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No