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NCT Number: NCT03125512

Positional Therapy Versus CPAP for Positional OSA

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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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore, 529889

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

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.

Continuous Positive Airway Pressure

Device

Automated adjusting continuous positive airway pressure

Primary outcomes

  1. 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

Secondary outcomes

  1. Functional Outcomes of Sleep Questionnaire ( FOSQ)

    Time frame: 8 weeks after the beginning of each intervention

    Difference in FOSQ

  2. 36-Item Short Form Survey (SF-36)

    Time frame: 8 weeks after the beginning of each intervention

    Difference in SF-36

  3. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 8 weeks after the beginning of each intervention

    Difference in PSQI

  4. Apnea-hypopnea Index ( AHI, events/hr)

    Time frame: 8 weeks after the beginning of each intervention

    Difference in AHI

  5. DASS21 questionnaire

    Time frame: 8 weeks after the beginning of each intervention

    Difference in mood symptoms ( DASS21)

  6. 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

  7. Patient preference

    Time frame: Upon study completion at week 17

    patient preference for treatment modality will be assessed via a questionnaire

  8. Oxygen desaturation index (3%) and lowest oxygen saturation ( %)

    Time frame: 8 weeks after the beginning of each intervention

    Oxygen indices

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2017
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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