Randomized Experiment of Sleep Technology

NCT04246424 | Completed

• 1 other identifier: 00117330
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Short sleep duration is highly prevalent and linked to negative mental and physical health consequences, including increased cardiovascular disease risk \[1\]. According to data from the National Health Interview Survey, 70.1 million U.S. adults (29.2%) sleep \<6 hours per 24 hour period \[2\]. These statistics are a stark contrast to recommendations made by a recent consensus panel of sleep experts that concluded "at least 7 hours" is the amount of sleep needed for health and performance among adults \[3\]. Therefore, a high number of U.S. adults could benefit from extending sleep duration. Several small experiments have demonstrated the benefits of short-term sleep extension \[4-8\]. However, these studies are limited by extending sleep as a temporary experimental manipulation rather than a longer-term behavioral intervention. To deliver sleep extension interventions, wearable sleep trackers may be useful, particularly given the rapid uptake among consumers (+500% in 3 years) \[9\]. We have developed a novel technology-assisted behavioral sleep extension intervention that employs four elements -- a wearable sleep tracker, didactic content, an interactive smartphone feature and brief telephone counseling. User testing supports feasibility of extending sleep, but little is known about the effects of differing types of technology interventions on sleep. Therefore, the goal of this study is to examine the differences between technology sleep extension interventions and sleep duration.

Conditions

Sleep

Outcome Measures

Primary Outcomes (3)

• Sleep Duration (Assess changes in sleep quality)

  Assess changes in sleep quality:Using the Philips Respironics Actiwatch (scoring completed using Philips Actiware 6), sleep duration and sleep quality will be assessed. Measures include bed/wake time, total time in bed, total sleep time, onset latency, sleep efficiency, number of awakenings and minutes awake during the night, or Wake After Sleep Onset (WASO). White, red, green and blue light will be measured using the device but only white light will be used in the assessment.

  time points at visit 1 (week 1), visit 2 (week 6) and visit 3 (week 12)

• Sleep Duration

  Assesses changes in daytime sleepiness: Using questionnaires Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment (2008-2012 PROMIS Health Organization and PROMIS Cooperative Group)

  time points at visit 1 (week 1), visit 2 (week 6) and visit 3 (week 12)

• Sleep Duration

  Assesses changes in daytime sleepiness: Munich Chronotype Questionnaire (Chronotype(en) 2008 Till Roenneberg, \& Martha Merrow, LMU Munich) , daytime sleepiness and changes over the three time points will be assessed.

  time points at visit 1 (week 1), visit 2 (week 6) and visit 3 (week 12)

Study Arms (4)

Fitbit + Coaching

ACTIVE COMPARATOR

Fitbit + coaching will receive both the fitbit and coaching interventions.

Behavioral: Fibit + Coaching

Coaching

ACTIVE COMPARATOR

Coaching group will receive weekly remote coaching lessons by phone email or text for 1-6 weeks. They will also receive a weekly email lesson for 1-6 weeks on things such as basics of sleep, enhancing sleep environment and managing stress.

Behavioral: Coaching

Fitbit

ACTIVE COMPARATOR

Fitbit group will receive a Fitbit and are asked to monitor their sleep over the smartphone application for 1-6 weeks.

Behavioral: Fitbit

Self-management

NO INTERVENTION

Self-management participants will be given some information of improving sleep but asked to keep their same schedule. Once their participation concludes, they will be given the opportunity to receive a fitbit and coaching if they so choose.

Interventions

Fibit + Coaching BEHAVIORAL

This intervention is a combination of the coaching and fitbit interventions

Fitbit + Coaching

Coaching BEHAVIORAL

Coaching Participants who are assigned coaching group will receive telephone coaching. Coaches follow a guide developed by Kelly Glazer Baron, Jennifer Duffecy, Kathryn Reid, and Lauren Caccamo. The first session is an approximately 30 minute engagement session, with the purpose of "getting to know" the participant to increase likelihood for participation. The end goal is to have participants express Desire, Ability, Reason, Need, Can (DARN-C) to make changes in sleep). The remainder calls (week 2-6) are follow-up calls lasting about 5 minutes. The goal of these calls is to keep participants motivated and address any issues with the Fitbit hard or software. Participants will also receive weekly email lessons to their personal email address for 1-6 weeks.

Coaching

Fitbit BEHAVIORAL

Fitbit Participants in the fitbit group will receive a Fitbit Charge 3 black, and asked to wear it for 1-6 weeks. Participants will monitor their sleep through the sleep section in the Fitbit app on the smartphone. Participants will be provided login information so that researchers can access this data and asked to keep Bluetooth on. After week 6, participants can choose to continue to wear the device for the duration of the study (12 weeks). Though wear at weeks 7-12 is not required, researchers will still use any data that was collected from the fitbit during that time. At the completion of their participation, researchers retain the login information and the device is switched to a personal login of the participants choice.

Fitbit

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \>25 kg/m2
• Short sleep duration (\<6.5 hrs of sleep per night, on average)

You may not qualify if:

• High risk or presence of restless legs syndrome or insomnia as assessed by the screening questionnaires,
• History of cognitive or neurological disorders;
• Presence of any major psychiatric disorder, current alcohol or substance abuse;
• Unstable or serious medical illness;
• Shift work or travel over 2 time zones in the past 2 months,
• Inability to read and write English,
• Pregnancy or desire to become pregnant during the study period,
• Significant environmental factors disturbing sleep (e.g. awakenings \>4 per week due to caregiving responsibilities),
• \>8 hours in bed on average,
• engaged in special diet for weight loss (e.g., diet post weight loss surgery),
• use of hypnotics within the past three months.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Family and Preventive Medicine

Salt Lake City, Utah, 84108, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: January 29, 2020
• Study Start: January 16, 2019
• Primary Completion: April 27, 2020
• Study Completion: April 27, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

US (1)