Efficacy of a Novel Sleep Intervention in Short Sleepers

NCT04697680 | Withdrawn

• 1 other identifier: 1812207442
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 1/3 of Americans sleep ≤6h per night, an amount that has been deemed sub-optimal by the American Academy of Sleep Medicine and Sleep Research Society, the National Sleep Foundation, American Thoracic Society, and the American Heart Association. These consensus statements echo findings from many reviews on this topic. This is alarming, given epidemiologic and experimental research showing that reduced sleep time is associated with a variety of negative health outcomes including obesity, diabetes, cardiovascular disease, and mortality. Different people may need different amounts of sleep. And some people may not be able to make large changes to their sleep schedule all at once. Many individuals have situational constraints that change over time. As such, short sleep represents an unmet public health problem. There are, however, no empirically supported interventions for insufficient sleep. The proposed study addresses this critical gap by evaluating the efficacy of a novel intervention that is theoretically grounded, feasible, and has positive impacts on sleep duration. The intervention in the proposed study is by design self-correcting, individually-tailored, and not dependent on unknown individual sleep needs. It can adapt to any schedule and situation and can adapt to changes in a person's sleep schedule. The main goal of this study is to evaluate whether a manually determined sleep extension intervention is effective at improving sleep and related outcomes among adults who find it difficult to get enough sleep.

Conditions

Sleep

Keywords

Sleep Extension; Actigraphy; Sleep Diaries; Sleep Efficiency

Outcome Measures

Primary Outcomes (2)

• Change in Sleep Duration

  Sleep duration will be assessed using Fitbit devices and/or sleep diaries.

  Change in sleep duration from baseline and then every 7 days, over a period of 8 weeks.

• Change in Sleep Efficiency

  Sleep efficiency will be manually calculated using information from Fitbit devices and/or sleep diaries.

  Change in sleep efficiency from baseline and then every 7 days, over a period of 8 weeks.

Secondary Outcomes (21)

• Change in Pittsburgh Sleep Quality Index (PSQI) scores across an eight (8) week study

  Change from baseline and then at end of study [Day 57]

• Change in Insomnia Severity Index (ISI) scores across an eight (8) week study

  Change from baseline and then at end of study [Day 57]

• Change of Epworth Sleepiness Scale (ESS) scores across an eight (8) week study

  Change from baseline and then at end of study [Day 57]

• Change in Perceived Stress Scale (PSS) scores across an eight (8) week study

  Change from baseline and then at end of study [Day 57]

• Change in Profile of Mood States (POMS) scores across an eight (8) week study

  Change from baseline and then at end of study [Day 57]

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Subjects randomized into Group 1 will be provided with a sleep schedule each week based on an algorithm (Algorithm 1) calculated from sleep diaries and fitbit data. Subjects will complete questionnaires at an initial clinic visit. Subjects will then complete a sleep diary upon waking each day and wear a Fitbit Charge 2 device for sleep monitoring each day for 8 weeks. At the end of the study, subjects will complete follow-up questionnaires at a final clinic visit.

Behavioral: Algorithm 1

Group 2

ACTIVE COMPARATOR

Subjects randomized into Group 2 will be provided with a sleep schedule each week based on an algorithm (Algorithm 2) calculated from sleep diaries and fitbit data. Subjects will complete questionnaires at an initial clinic visit. Subjects will then complete a sleep diary upon waking each day and wear a Fitbit Charge 2 device for sleep monitoring each day for 8 weeks. At the end of the study, subjects will complete follow-up questionnaires at a final clinic visit.

Behavioral: Algorithm 2

Group 3

ACTIVE COMPARATOR

Subjects randomized into Group 1 will be provided with a sleep schedule each week based on an algorithm (Algorithm 3) calculated from sleep diaries and fitbit data. Subjects will complete questionnaires at an initial clinic visit. Subjects will then complete a sleep diary upon waking each day and wear a Fitbit Charge 2 device for sleep monitoring each day for 8 weeks. At the end of the study, subjects will complete follow-up questionnaires at a final clinic visit.

Behavioral: Algorithm 3

Interventions

Algorithm 1 BEHAVIORAL

A sleep extension algorithm (algorithm 1) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data.

Group 1

Algorithm 2 BEHAVIORAL

A sleep extension algorithm (algorithm 2) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data.

Group 2

Algorithm 3 BEHAVIORAL

A sleep extension algorithm (algorithm 3) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data.

Group 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be between the ages of 18-60 years old
• Have a typical sleep schedule of \<6 hours per night

You may not qualify if:

• Any condition that the PI considers would significantly impede participation in the study.
• Participant is under 18 years of age or older than 60 years of age
• Do not have a typical sleep schedule of \<6 hours per night

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Sleep and Health Research Program, Associate Professor

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: January 15, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 31, 2025

Record last verified: 2021-02

Locations

US (1)