Status:
UNKNOWN
Testing Utility of Commercially Available Sleep Trackers for Physician-Patient Communication
Lead Sponsor:
Regenstrief Institute, Inc.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
National Sleep Foundation
Conditions:
Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
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 cond...
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 exer...
Eligibility Criteria
Inclusion
- 18 and older
- Have insomnia as identified by electronic record and/or a validated questionnaire
- 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
- Not English speaking
- Have ischemic or hemorrhagic cerebrovascular disease affecting collection of study outcomes (via ICD codes I6\*, 43\*)
- History of dementia (via ICD codes F0\*, 290\*)
- History of Bipolar/Schizophrenia/Depression (via ICD codes F2\*, F31\*, 296\*, 295\*)
- History of alcohol or substance abuse (via ICD codes F1\*, 304\*, 303\*)
- Incarcerated/Long Term Care (LTC)
- Unable to complete study questionnaires due to hearing loss or blindness
Key Trial Info
Start Date :
June 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03795129
Start Date
June 10 2018
End Date
February 28 2019
Last Update
January 7 2019
Active Locations (1)
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1
Regenstrief Institute
Indianapolis, Indiana, United States, 46202