NCT03125512

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.8 years

First QC Date

April 9, 2017

Last Update Submit

May 5, 2019

Conditions

Sleep Apnea Syndromes

Keywords

Sleep Apnea SyndromesPositional sleep apneaCPAPNight Shift

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Functional Outcomes of Sleep Questionnaire ( FOSQ)

    8 weeks after the beginning of each intervention

  • 36-Item Short Form Survey (SF-36)

    8 weeks after the beginning of each intervention

  • Pittsburgh Sleep Quality Index (PSQI)

    8 weeks after the beginning of each intervention

  • Apnea-hypopnea Index ( AHI, events/hr)

    8 weeks after the beginning of each intervention

  • DASS21 questionnaire

    8 weeks after the beginning of each intervention

  • +3 more secondary outcomes

Study Arms (2)

Night Shift positional device

EXPERIMENTAL

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

Continuous positive airway pressure

ACTIVE COMPARATOR

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

Interventions

Night Shift positional deviceDEVICE

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.

Night Shift positional device
continuous positive airway pressureDEVICE

Automated adjusting continuous positive airway pressure

Continuous positive airway pressure

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 31896735DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Yingjuan Mok, MBBS

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research staff assessing the outcomes of the study, the scoring of the sleep studies, and data analyses will be blinded.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 8-week randomized crossover trial with a 1 week washout period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2017

First Posted

April 24, 2017

Study Start

February 27, 2017

Primary Completion

December 10, 2018

Study Completion

December 30, 2018

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

SG(1)