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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775291
Recruitment Status : Active, not recruiting
First Posted : December 13, 2018
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
Fitbit Inc

Brief 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. 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.

Condition or disease Intervention/treatment
Sleep Apnea Diagnostic Test: Simultaneous assessment of sleep apnea by polysomnogram and wearable device

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Study Type : Observational
Actual Enrollment : 303 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Fitbit Sleep Apnea Alert Software Validation Study
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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]


Secondary Outcome Measures :
  1. 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]

  2. 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 .



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775291


Locations
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United States, Alabama
Jasper Summit Research
Jasper, Alabama, United States, 35501
United States, California
Peninsula Sleep Center
Burlingame, California, United States, 94010
Sleep Center Orange County
Irvine, California, United States, 92604
United States, Georgia
Neurotrials Inc
Atlanta, Georgia, United States, 30342
United States, South Carolina
SleepMed Inc
Columbia, South Carolina, United States, 29201
Ireland
St Vincent's University Hospital
Dublin, Ireland
Sponsors and Collaborators
Fitbit Inc
Investigators
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Study Director: Conor Heneghan, PhD Fitbit Inc
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Responsible Party: Fitbit Inc
ClinicalTrials.gov Identifier: NCT03775291    
Other Study ID Numbers: 129-0318-01
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases