NCT03795129

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Regenstrief Institute, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	SleepLife Application w/FitBit	Subjects receive a FitBit. Subjects receive access to the SleepLife Application. Subjects receive training and assistance setting up use and access to the SleepLife Application. Subjects' physicians will receive subject sleep data. Subjects and physicians have the option of messaging each other through the SleepLife application.
BEHAVIORAL	FitBit w/Minimal to No SleepLife App.	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.

Timeline

• Start date: 2018-06-10
• Primary completion: 2018-12-31
• Completion: 2019-02-28
• First posted: 2019-01-07
• Last updated: 2019-01-07

Locations

1 site across 1 country: United States