Testing Utility of Commercially Available Sleep Trackers for Physician-Patient Communication

Regenstrief Institute

Status: Unknown

Conditions: Insomnia

Treatments: Behavioral: FitBit w/Minimal to No SleepLife App.; Behavioral: SleepLife Application w/FitBit

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03795129

Merck - 34

Details and patient eligibility

About

Sleep related disorders are common in primary care practice. Sleep wear related data has not been utilized to improve sleep related communication between patients and providers. The study team is conducting a randomized study to improve physical-patient communication regarding sleep through a novel intervention based upon sleep wear and the Sleeplife® app.

Full description

Based on a National US survey in 2012, 69% adults track at least one health indicator using either a tracking device or some other means. The main health indicators tracked were diet, weight, and exercise. Although not as extensive as the above health indicators, certain studies also looked at sleep indicators through the trackers to support validity of their use. Based on the study team's literature review, none of the studies looked at an intervention designed to utilize data-trackers-based data to improve physician-patient communication regarding sleep.

Commercially available and inexpensive exercise, fitness and sleep trackers are broadly available and consumer use is growing rapidly. Industry analysts estimate that over 30 million Americans have access to their sleep tracking data (e.g. Fitbit. Jawbone). Physicians seldom use patient-generated (i.e. subjective) sleep data (e.g. sleep diaries) and have been slow to integrate objective sleep data collected from commercial sleep trackers. Two commercial sleep trackers have been validated by independent testing. The National Sleep Foundation (NSF) has led recent efforts to establish normative data (i.e. appropriate ranges) for sleep duration and sleep quality. NSF, together with the Consumer Electronics Association (now Consumer Technology Association), has established a work-group involving over 40 sleep tracking technology companies which is working to standardize sleep tracking data collection and reporting. Finally, NSF has developed a tool ("SleepLife") that translates data retrieved from all commercially available sleep trackers into a personal sleep tracking record. This product has been tested rigorously for two years and publicly released in January 2016. These developments present the timely opportunity to test a new paradigm for patient and physician communication using objective patient data (sleep).

The study team will utilize a combination of observational and interventional study designs to achieve study objectives.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18 and older

2. Have insomnia as identified by electronic record and/or a validated questionnaire

3. Prescription medication for insomnia with International Classification of Disease (ICD) codes: 327.*, 780.5*, 347.*; icd-10's G47* and medications: Ambien (zolpidem), Belsomra (suvorexant), Butisol (butabarbital), Doral (quazepam), Edluar (zolpidem), Estazolam, Flurazepam, Halcion (triazolam), Hetlioz (tasimelteon), Intermezzo (zolpidem), Lunesta (eszopiclone), Restoril (temazepam), Rozerem (ramelteon), Seconal (secobarbital), Silenor (doxepin), Sonata (zaleplon), and Zolpimist (zolpidem)

4. English speaking 4. Consentable in-person 5. Have access to a telephone with smart phone capabilities. (iOS/Android)

Exclusion criteria

1. Not English speaking
2. Have ischemic or hemorrhagic cerebrovascular disease affecting collection of study outcomes (via ICD codes I6*, 43*)
3. History of dementia (via ICD codes F0*, 290*)
4. History of Bipolar/Schizophrenia/Depression (via ICD codes F2*, F31*, 296*, 295*)
5. History of alcohol or substance abuse (via ICD codes F1*, 304*, 303*)
6. Incarcerated/Long Term Care (LTC)
7. Unable to complete study questionnaires due to hearing loss or blindness

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

SleepLife Application w/FitBit

Experimental group

Description:

Subject receives a FitBit. Subjects receive access to the SleepLife Application. Subjects receive training and assistance setting up use and access to the SleepLife Application. Subject physicians will receive subject sleep data. Subject and physicians have the option of messaging each other through the SleepLife application.

Treatment:

Behavioral: SleepLife Application w/FitBit

FitBit w/Minimal to No SleepLife App.

Active Comparator group

Description:

Subjects will receive a FitBit Subjects will be told about the SleepLife Application (but not be shown how to access it). Subjects will receive no training with regard to how to access SleepLife Application. Subjects' physicians will receive no subject sleep data.

Treatment:

Behavioral: FitBit w/Minimal to No SleepLife App.