Obstructive Sleep Apnea SyndromeNCT02967367
Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome
A study testing Jawbone sleep tracker, Withings sleep tracker and BodyMedia Sense Wear accelerometer in people with Obstructive Sleep Apnea Syndrome, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Jawbone sleep tracker, Withings sleep tracker and BodyMedia Sense Wear accelerometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high clinical suspicion of obstructive sleep apnea syndrome
Who cannot join
- other associated sleep disorder
- inability to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
During last years, numerous sleep trackers have been commercialized. They are working on accelerometer-based technology. 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 our study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Jawbone sleep tracker, Withings sleep tracker, BodyMedia Sense Wear accelerometer
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jawbone sleep trackerDevice
Also called accelerometer
During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Withings sleep trackerDevice
During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
BodyMedia Sense Wear accelerometerDevice
During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Jawbone sleep tracker; Device: Withings sleep tracker; Device: BodyMedia Sense Wear accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Bed
time spent in bed during the night (minutes)
Measured: one night (up to 600 minutes)
Sleep Efficiency
a percentage corresponding to total sleep time divided by time in bed
Measured: one night (up to 600 minutes)
Total Sleep Time
time spent sleeping during the night (minutes)
Measured: one night (up to 600 minutes)
Secondary outcomes (2)
Deep Sleep
a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time
Measured: one night (up to 600 minutes)
Light Sleep
a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time
Measured: one night (up to 600 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Bruyneel, MD PhD, Principal investigator, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967367
- Sponsor's protocol ID
- AK/15-06-67/4522
- Status last verified
- Feb 2019
- First submitted
- 5 Sep 2016
- Last updated
- 24 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT02967367
- Acronym / sponsor ID
- AK/15-06-67/4522
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Posted 24 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During last years, numerous sleep trackers have been commercialized. They are working on accelerometer-based technology. 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 our study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jawbone/Withings sleep trackers, Bodymedia Sensewear | Experimental | Device: Jawbone sleep tracker, Device: Withings sleep tracker, Device: BodyMedia Sense Wear accelerometer2 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- high clinical suspicion of obstructive sleep apnea syndrome
Key exclusion criteria (2 listed)
- other associated sleep disorder
- inability to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jawbone sleep trackerAlso: accelerometerDuring one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient | Device | Jawbone/Withings sleep trackers, Bodymedia Sensewear |
| Withings sleep trackerDuring one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient | Device | Jawbone/Withings sleep trackers, Bodymedia Sensewear |
| BodyMedia Sense Wear accelerometerDuring one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient | Device | Jawbone/Withings sleep trackers, Bodymedia Sensewear |
Primary outcome
Time in Bed
Time frame: one night (up to 600 minutes)
time spent in bed during the night (minutes)
Sleep Efficiency
Time frame: one night (up to 600 minutes)
a percentage corresponding to total sleep time divided by time in bed
Total Sleep Time
Time frame: one night (up to 600 minutes)
time spent sleeping during the night (minutes)
2 secondary outcomes
Deep Sleep
Time frame: one night (up to 600 minutes)
Light Sleep
Time frame: one night (up to 600 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea Syndrome
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Bruyneel, MD PhD principal investigator
Centre Hospitalier Universitaire Saint Pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jawbone sleep tracker, Withings sleep tracker and BodyMedia Sense Wear accelerometer in people with Obstructive Sleep Apnea Syndrome, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Bed (time frame: one night (up to 600 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.