Clinical trial NCT03795129: Testing Utility of Commercially Available Sleep Trackers for Physician-Patient Communication
Official title: Testing Utility of Commercially Available Sleep Trackers for Physician-Patient Communication Around Sleep Experience, Habits, and Behaviors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Early awakening
Lead sponsor: Regenstrief Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: National Sleep Foundation
First posted: 2019-01-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a cluster randomized trial that is randomized at the clinic level.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of physicians using a commercially available sleep tracker assessed by the "Physician Satisfaction/Communication" questionnaire who saw an improvement in physician-patient dialogue regarding sleep and related behaviors and habits
timeFrame: Six Months
measure: Number of patient-physician communicationdialog assessed by using a commercially available sleep tracker assessed by the "Patient Satisfaction" questionnaire.
timeFrame: Six Months
Secondary outcomes:
measure: Number of physician subjects with satisfaction with sleep counseling that improves when presented with objective patient sleep data.
timeFrame: Six Months
measure: Number of patients who feel that their communication with their physician has improved as a result of the program as measured by the "Patient Satisfaction" survey.
timeFrame: Six Months
Other outcomes:
measure: To determine if data improves over time for measures related to total sleep time (TST) and satisfaction with sleep.
timeFrame: Six Months
Locations:
city: Indianapolis
country: United States
facility: Regenstrief Institute
state: Indiana
Study officials:
affiliation: Regenstrief Institute, Inc.
name: Babar Khan, MD
role: PRINCIPAL_INVESTIGATOR
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