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Positional Therapy Versus CPAP for Positional OSA

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ClinicalTrials.gov Identifier: NCT03125512
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Changi General Hospital

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).

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Device: Night Shift positional device Device: continuous positive airway pressure Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 8-week randomized crossover trial with a 1 week washout period.
Masking: Single (Outcomes Assessor)
Masking Description: Research staff assessing the outcomes of the study, the scoring of the sleep studies, and data analyses will be blinded.
Primary Purpose: Treatment
Official Title: Comparing a Convenient Positional Therapy Device to CPAP for Treatment of Positional Obstructive Sleep Apnea, A Crossover Randomized Controlled Trial
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: Continuous positive airway pressure
Randomized to CPAP first for 8 weeks, followed by positional therapy for 8 weeks, with a 1 week washout period.
Device: continuous positive airway pressure
Automated adjusting continuous positive airway pressure




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125512


Contacts
Contact: Yingjuan Mok, MBBS 68502600 ying_juan_mok@cgh.com.sg
Contact: Nur Shameerah Abdul Halim 68502600 Nur_Shameerah@cgh.com.sg

Locations
Singapore
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Yingjuan Mok, MBBS       ying_juan_mok@cgh.com.sg   
Sponsors and Collaborators
Changi General Hospital
Investigators
Principal Investigator: Yingjuan Mok, MBBS Changi General Hospital

Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT03125512     History of Changes
Other Study ID Numbers: OSA_RCT
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Changi General Hospital:
Sleep Apnea Syndromes
Positional sleep apnea
CPAP
Night Shift

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases