Severe Sleep ApneaNCT02744235
Mainstream Sleep Tracking Devices vs Polysomnography
A study testing Polysomnography Data, Jawbone UP® and Fitbit Charge ® in people with Severe Sleep Apnea and Severe Insomnia, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to compare two popular portable sleep monitoring devices-the Fitbit Charge®, Jawbone UP®, and SleepTime smartphone app-to the "gold standard" Polysomnography (PSG). Parameters that will be analyzed include sleep onset latency, sleep efficiency, and sleep staging. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Sleep Apnea, Severe Insomnia, Epileptiform Activity
- What is being tested?
- Polysomnography Data, Jawbone UP® and Fitbit Charge ®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing Polysomnography
Who cannot join
- severe sleep apnea
- severe insomnia with less than two hours of sleep per night
- epileptiform activity
- electrical status epilepticus of sleep
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Sensitivity and Specificity of Mainstream Sleep Tracking Devices Compared to Polysomnography
The purpose of this study is to compare two popular portable sleep monitoring devices-the Fitbit Charge®, Jawbone UP®, and SleepTime smartphone app-to the "gold standard" Polysomnography (PSG). Parameters that will be analyzed include sleep onset latency, sleep efficiency, and sleep staging. Specifically, this study will investigate the validity of the Jawbone UP®, Fitbit Charge®, and SleepTime app in detecting sleep and wakefulness in comparison to conventional Polysomnography (PSG).
- Conditions
- Severe Sleep Apnea, Severe Insomnia, Epileptiform Activity
- Being tested
- Polysomnography Data, Jawbone UP®, Fitbit Charge ®
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysomnography DataDevice
Jawbone UP®Device
Fitbit Charge ®Device
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing Polysomnography | Other | Not described Receives: Device: Polysomnography Data; Device: Jawbone UP®; Device: Fitbit Charge ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time it takes subject to fall asleep
Measured: Up to 3 Months
Number of Minutes of Sleep
Measured: Up to 3 Months
Number of Arousals
Measured: Up to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Unable to move forward due to funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Sleep ApneaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alcibiades Rodriguez, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744235
- Sponsor's protocol ID
- 15-00071
- Status last verified
- Apr 2017
- First submitted
- 13 Apr 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of Mainstream Sleep Tracking Devices Compared to Polysomnography
- ClinicalTrials.gov ID
- NCT02744235
- Acronym / sponsor ID
- 15-00071
- Conditions
- Severe Sleep Apnea, Severe Insomnia, Epileptiform Activity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to move forward due to funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two popular portable sleep monitoring devices-the Fitbit Charge®, Jawbone UP®, and SleepTime smartphone app-to the "gold standard" Polysomnography (PSG). Parameters that will be analyzed include sleep onset latency, sleep efficiency, and sleep staging. Specifically, this study will investigate the validity of the Jawbone UP®, Fitbit Charge®, and SleepTime app in detecting sleep and wakefulness in comparison to conventional Polysomnography (PSG).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Polysomnography | Other | Device: Polysomnography Data, Device: Jawbone UP®, Device: Fitbit Charge ® |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing Polysomnography
Key exclusion criteria (4 listed)
- severe sleep apnea
- severe insomnia with less than two hours of sleep per night
- epileptiform activity
- electrical status epilepticus of sleep
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 |
|---|---|---|
| Polysomnography Data | Device | Patients undergoing Polysomnography |
| Jawbone UP® | Device | Patients undergoing Polysomnography |
| Fitbit Charge ® | Device | Patients undergoing Polysomnography |
Primary outcome
Time it takes subject to fall asleep
Time frame: Up to 3 Months
Number of Minutes of Sleep
Time frame: Up to 3 Months
Number of Arousals
Time frame: Up to 3 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
Related trials for Severe Sleep Apnea
Recruiting
Identification of Biomarkers of Obstructive Sleep Apnea.
Obstructive Sleep Apnea, Obstructive Sleep Apnea (OSA)
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.
Alcibiades Rodriguez principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography Data, Jawbone UP® and Fitbit Charge ® in people with Severe Sleep Apnea and Severe Insomnia, run by NYU Langone Health at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 27 Apr 2017. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 it takes subject to fall asleep (time frame: Up to 3 Months). 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 27 Apr 2017; AzTrials last refreshed its copy on 26 Oct 2026.