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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

303 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-09

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Is My Sleep Tracker Tracking my Sleep?

NCT06174558

Obstructive Sleep Apnea

NOT_YET_RECRUITING

Clinical Validation of New Commercial Sleep Monitoring Devices

NCT02779543

Sleep Apnea

COMPLETED NA

Technical Feasibility Study on Screening Sleep Related Breathing Disturbances and Sleep Apnoea With Wearable Sensors

NCT05235984

Sleep Apnea Sleep Disorder

COMPLETED

Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP

NCT05960175

OSA

RECRUITING NA

Evaluating an Under-mattress Sleep Monitor Compared to a Peripheral Arterial Tonometry Device in the Diagnosis of Obstructive Sleep Apnea

NCT04778748

Sleep Apnea, Obstructive

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Simultaneous assessment of sleep apnea by polysomnogram and wearable device

Intervention Type DIAGNOSTIC_TEST

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.

Simultaneous assessment of sleep apnea by polysomnogram and wearable device

Intervention Type DIAGNOSTIC_TEST

Characterization of sleep apnea by lab-based polysomnogram

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simultaneous assessment of sleep apnea by polysomnogram and wearable device

Characterization of sleep apnea by lab-based polysomnogram

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes