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Positional Therapy Versus CPAP for Positional OSA

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ClinicalTrials.gov Identifier: NCT03125512
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Changi General Hospital

Tracking Information
First Submitted Date  ICMJE April 9, 2017
First Posted Date  ICMJE April 24, 2017
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE February 27, 2017
Actual Primary Completion Date December 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Functional Outcomes of Sleep Questionnaire ( FOSQ) [ Time Frame: 8 weeks after the beginning of each intervention ]
    Difference in FOSQ
  • 36-Item Short Form Survey (SF-36) [ Time Frame: 8 weeks after the beginning of each intervention ]
    Difference in SF-36
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 weeks after the beginning of each intervention ]
    Difference in PSQI
  • Apnea-hypopnea Index ( AHI, events/hr) [ Time Frame: 8 weeks after the beginning of each intervention ]
    Difference in AHI
  • DASS21 questionnaire [ Time Frame: 8 weeks after the beginning of each intervention ]
    Difference in mood symptoms ( DASS21)
  • 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
  • Patient preference [ Time Frame: Upon study completion at week 17 ]
    patient preference for treatment modality will be assessed via a questionnaire
  • Oxygen desaturation index (3%) and lowest oxygen saturation ( %) [ Time Frame: 8 weeks after the beginning of each intervention ]
    Oxygen indices
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • Functional Outcomes of Sleep Questionnaire ( FOSQ) [ Time Frame: 8 weeks after the beginning of each intervention ]
    Difference in FOSQ
  • 36-Item Short Form Survey (SF-36) [ Time Frame: 8 weeks after the beginning of each intervention ]
    Difference in SF-36
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 weeks after the beginning of each intervention ]
    Difference in PSQI
  • Apnea-hypopnea Index ( AHI) [ Time Frame: 8 weeks after the beginning of each intervention ]
    Difference in AHI
  • DASS21 questionnaire [ Time Frame: 8 weeks after the beginning of each intervention ]
    Difference in mood symptoms ( DASS21)
  • Patient adherence [ Time Frame: 8 weeks after the beginning of each intervention ]
    Compare patient adherence based on device download information
  • Patient preference [ Time Frame: Upon study completion at week 17 ]
    patient preference for treatment modality will be assessed via a questionnaire
  • Oxygen desaturation index (ODI) and lowest oxygen saturation ( SpO2) [ Time Frame: 8 weeks after the beginning of each intervention ]
    Oxygen indices
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Positional Therapy Versus CPAP for Positional OSA
Official Title  ICMJE Comparing a Convenient Positional Therapy Device to CPAP for Treatment of Positional Obstructive Sleep Apnea, A Crossover Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Sleep Apnea Syndromes
Intervention  ICMJE
  • 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.
  • Device: continuous positive airway pressure
    Automated adjusting continuous positive airway pressure
Study Arms  ICMJE
  • 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.
    Intervention: Device: Night Shift positional device
  • 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.
    Intervention: Device: continuous positive airway pressure
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2019)
41
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2017)
40
Actual Study Completion Date  ICMJE December 30, 2018
Actual Primary Completion Date December 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03125512
Other Study ID Numbers  ICMJE OSA_RCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Changi General Hospital
Study Sponsor  ICMJE Changi General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yingjuan Mok, MBBS Changi General Hospital
PRS Account Changi General Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP