Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch

August 18, 2022 updated by: Fitbit Inc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
303

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • St Vincent's University Hospital
  • United States
    • Alabama
      • Jasper, Alabama, United States, 35501
        • Jasper Summit Research
    • California
      • Burlingame, California, United States, 94010
        • Peninsula Sleep Center
      • Irvine, California, United States, 92604
        • Sleep Center Orange County
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Neurotrials Inc
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Sleepmed Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Diagnostic test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device
Characterization of sleep apnea by lab-based polysomnogram
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.
Diagnostic test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device
Characterization of sleep apnea by lab-based polysomnogram

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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]
Nightly basis averaged over 7 nights.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Single night comparison between PSG and wearable device data on a per-subject basis
Time Frame: 1 night
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]
1 night
Single night comparison between PSG and wearable device data on a per-epoch basis
Time Frame: 1 night
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 .
1 night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fitbit Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Conor Heneghan, PhD, Fitbit Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 129-0318-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No: There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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