Recruiting

Observational Study

Sponsor:

Regenstrief Institute, Inc.

Code:

NCT03795129

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

SleepLife Application w/FitBit

FitBit w/Minimal to No SleepLife App.

Study Details

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.

Conditions

Insomnia

Study ID

NCT03795129

Start date

Jun 10, 2018

Status verified date

Jan, 2019

Completion date

Feb 28, 2019

Anticipated

Primary completion date

Dec 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: SleepLife Application w/FitBit

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.

active comparator: 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.

Interventions

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.

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.

Primary outcome 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 [ Time Frame: Six Months ]
  • Number of patient-physician communicationdialog assessed by using a commercially available sleep tracker assessed by the "Patient Satisfaction" questionnaire. [ Time Frame: Six Months ]

Central Contacts and Locations

Central contacts

Jarod R Baker, MS

317-274-9274bakerjar@regenstrief.org

Bridget A Fultz

317-274-9088bafultz@iupui.edu

Locations

Regenstrief Institute

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Lori Rawlings

317-274-9052rawlingl@regenstrief.org

More Information

Sponsor

Regenstrief Institute, Inc.

Last update posted

Jan 7, 2019

Last verified

Jan, 2019

Keywords

  • Early awakening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regenstrief Institute, Inc. on 2019-01-07.