NCT02967367

Brief Summary

During last years, numerous sleep trackers have been commercialized. They are intended to give indications about sleep quality/duration in order to give people an internet-based feedback about their own sleep. For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used routinely to assess objective sleep quality/patterns. Their use is also validated to estimate sleep in obstructive sleep apnea syndrome (OSA). The purpose of the present study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 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

September 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

March 24, 2020

Completed
Last Updated

March 24, 2020

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

September 5, 2016

Results QC Date

February 7, 2019

Last Update Submit

March 12, 2020

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (3)

  • Time in Bed

    time spent in bed during the night (minutes)

    one night (up to 600 minutes)

  • Sleep Efficiency

    a percentage corresponding to total sleep time divided by time in bed

    one night (up to 600 minutes)

  • Total Sleep Time

    time spent sleeping during the night (minutes)

    one night (up to 600 minutes)

Secondary Outcomes (2)

  • Deep Sleep

    one night (up to 600 minutes)

  • Light Sleep

    one night (up to 600 minutes)

Study Arms (1)

Jawbone/Withings sleep trackers, Bodymedia Sensewear

EXPERIMENTAL

2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients

Device: Jawbone sleep trackerDevice: Withings sleep trackerDevice: BodyMedia Sense Wear accelerometer

Interventions

Jawbone sleep trackerDEVICE

During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient

Also known as: accelerometer
Jawbone/Withings sleep trackers, Bodymedia Sensewear
Withings sleep trackerDEVICE

During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient

Jawbone/Withings sleep trackers, Bodymedia Sensewear
BodyMedia Sense Wear accelerometerDEVICE

During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient

Jawbone/Withings sleep trackers, Bodymedia Sensewear

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • high clinical suspicion of obstructive sleep apnea syndrome

You may not qualify if:

  • other associated sleep disorder
  • inability to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHu Saint Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Pr. Marie Bruyneel
Organization
CHU Saint-pierre
marie_bruyneel@stpierre-bru.be
00325354219

Study Officials

  • Marie Bruyneel, MD PhD

    Centre Hospitalier Universitaire Saint Pierre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

November 18, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 24, 2020

Results First Posted

March 24, 2020

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)