Sleep ApneaNCT03775291
Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch
An observational study of Sleep Apnea, run by Fitbit LLC at 6 sites in 2 countries.
Trial summary
This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Simultaneous assessment of sleep apnea by polysomnogram and wearable device
- How many people
- 303 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 9 Nov 2018to 30 Apr 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects referred to sleep labs for a clinical evaluation or subjects with previous sleep apnea who are known to be non-compliant with treatment.
Who may be able to join
- Capable of giving informed consent
- Comfortable reading the provided written study instructions in English (and/or local language) and using a smartphone in English (and/or local language).
- Have medical insurance either in the form of private insurance or a national health program.
Who cannot join
- No implanted cardiac devices
- Not pregnant. Pregnancy status will be confirmed per patient report of medical history, i.e., patients will be asked if they are pregnant or may be pregnant, and date of last menstrual cycle.
- No medical conditions which might lead to consistently low levels of perfusion in the vasculature at the wrist
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Neurotrials Inc
Atlanta, Georgia, 30342
Peninsula Sleep Center
Burlingame, California, 94010
SleepMed Inc
Columbia, South Carolina, 29201
Sleep Center Orange County
Irvine, California, 92604
Jasper Summit Research
Jasper, Alabama, 35501
About this study
Official title: Fitbit Sleep Apnea Alert Software Validation Study
This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea. The Sleep Apnea Alert software analyses data from a Fitbit commercially available wrist photoplethysmogram (PPG) device. The Sleep Apnea Alert software is an investigational software as medical device (SaMD) and is designed to retrospectively process data and flag users who have physiological signals consistent with an apnea-hypopnea index (AHI) of 15 or greater. This clinical validation study will be used to validate Fitbit's PPG-based sleep apnea algorithm. The outputs of the Fitbit Sleep Apnea Alert software will not be available to study participants, as the scope of this study is to gather validation data only and does not include testing product usability components.
- Conditions
- Sleep Apnea
- Being tested
- Simultaneous assessment of sleep apnea by polysomnogram and wearable device
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous assessment of sleep apnea by polysomnogram and wearable deviceDiagnostic test
Characterization of sleep apnea by lab-based polysomnogram
| Study group | Role | What they receive |
|---|---|---|
| Low pre-test likelihood for sleep apnea | Subjects at low risk for having sleep apnea due to lack of known risk factors and no complaints of symptoms related to sleep apnea (e.g., excessive daytime sleepiness) Receives: Diagnostic Test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device | |
| High pre-test likelihood for sleep apnea | Suspected sleep apnea patients who are undergoing sleep tests as part of normal medical care or are also known to be non-compliant with therapy. Receives: Diagnostic Test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of PSG-assessed AHI with multi-night estimate derived from wearable device.
Percent agreement between subjects classified as Apnea Hypopnea Index (AHI)≥15 or <15 as determined by a single night of lab based polysomnogram , versus the corresponding estimate (averaged over 7 nights) from the wearable device. [This primary outcome data will also be expressed as per-subject sensitivity and specificity of the wearable device to correctly identify subjects with AHI≥15 and AHI<15 respectively]
Measured: Nightly basis averaged over 7 nights.
Secondary outcomes (2)
Single night comparison between PSG and wearable device data on a per-subject basis
Percent agreement between subjects classified as Apnea Hypopnea Index (AHI)≥15 or <15 as determined by a single night of lab based polysomnogram , versus the corresponding estimate on the same night as PSG from the wearable device. [This primary outcome data will also be expressed as per-subject sensitivity and specificity of the wearable device to correctly identify subjects with AHI≥15 and AHI<15 respectively]
Measured: 1 night
Single night comparison between PSG and wearable device data on a per-epoch basis
Percent agreement on a per one-minute epoch basis for the presence of sleep apnea between the polysomnogram and the corresponding simultaneous estimate from the wearable device .
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start9 Nov 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fitbit LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Conor Heneghan, PhD, Study director, Fitbit LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775291
- Sponsor's protocol ID
- 129-0318-01
- Status last verified
- Aug 2022
- First submitted
- 3 Dec 2018
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitbit Sleep Apnea Alert Software Validation Study
- ClinicalTrials.gov ID
- NCT03775291
- Acronym / sponsor ID
- 129-0318-01
- Conditions
- Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Fitbit LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 13 Dec 2018 (actual)
- 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.
This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea. The Sleep Apnea Alert software analyses data from a Fitbit commercially available wrist photoplethysmogram (PPG) device. The Sleep Apnea Alert software is an investigational software as medical device (SaMD) and is designed to retrospectively process data and flag users who have physiological signals consistent with an apnea-hypopnea index (AHI) of 15 or greater. This clinical validation study will be used to validate Fitbit's PPG-based sleep apnea algorithm. The outputs of the Fitbit Sleep Apnea Alert software will not be available to study participants, as the scope of this study is to gather validation data only and does not include testing product usability components.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low pre-test likelihood for sleep apnea | – | Diagnostic Test: Simultaneous assessment of sleep apnea by polysomnogram and wearable deviceSubjects at low risk for having sleep apnea due to lack of known risk factors and no complaints of symptoms related to sleep apnea (e.g., excessive daytime sleepiness) |
| High pre-test likelihood for sleep apnea | – | Diagnostic Test: Simultaneous assessment of sleep apnea by polysomnogram and wearable deviceSuspected sleep apnea patients who are undergoing sleep tests as part of normal medical care or are also known to be non-compliant with therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred to sleep labs for a clinical evaluation or subjects with previous sleep apnea who are known to be non-compliant with treatment.
Key inclusion criteria (3 listed)
- Capable of giving informed consent
- Comfortable reading the provided written study instructions in English (and/or local language) and using a smartphone in English (and/or local language).
- Have medical insurance either in the form of private insurance or a national health program.
Key exclusion criteria (3 listed)
- No implanted cardiac devices
- Not pregnant. Pregnancy status will be confirmed per patient report of medical history, i.e., patients will be asked if they are pregnant or may be pregnant, and date of last menstrual cycle.
- No medical conditions which might lead to consistently low levels of perfusion in the vasculature at the wrist
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 |
|---|---|---|
| Simultaneous assessment of sleep apnea by polysomnogram and wearable deviceCharacterization of sleep apnea by lab-based polysomnogram | Diagnostic test | High pre-test likelihood for sleep apnea, Low pre-test likelihood for sleep apnea |
Primary outcome
Comparison of PSG-assessed AHI with multi-night estimate derived from wearable device.
Time frame: Nightly basis averaged over 7 nights.
Percent agreement between subjects classified as Apnea Hypopnea Index (AHI)≥15 or <15 as determined by a single night of lab based polysomnogram , versus the corresponding estimate (averaged over 7 nights) from the wearable device. [This primary outcome data will also be expressed as per-subject sensitivity and specificity of the wearable device to correctly identify subjects with AHI≥15 and AHI<15 respectively]
2 secondary outcomes
Single night comparison between PSG and wearable device data on a per-subject basis
Time frame: 1 night
Single night comparison between PSG and wearable device data on a per-epoch basis
Time frame: 1 night
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No. No: There is not a plan to make IPD available.
Related trials for Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation 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
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
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
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.
Conor Heneghan, PhD study director
Fitbit LLC
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by Fitbit LLC at 6 sites in 2 countries.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Ireland. 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?
Results are not available in the source record.
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?
Comparison of PSG-assessed AHI with multi-night estimate derived from wearable device. (time frame: Nightly basis averaged over 7 nights.). 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 22 Aug 2022.