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



Status:Recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:1/9/2019
Start Date:June 10, 2018
End Date:February 28, 2019
Contact:Jarod R Baker, MS
Email:bakerjar@regenstrief.org
Phone:317-274-9274

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Testing Utility of Commercially Available Sleep Trackers for Physician-Patient Communication Around Sleep Experience, Habits, and Behaviors

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.

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.

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)

3. 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
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Indianapolis, Indiana 46202
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