Hypknowledge Nationwide Sleep Extension

NCT ID: NCT07345767

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1038 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Short Sleep Duration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control

The control group receives standard feedback, where they will be asked to maintain a consistent sleep schedule irrespective of what the Fitbit data or sleep diary report.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention: Sleep Diary

This arm receives weekly feedback on their sleep schedule based on sleep diary data.

Group Type: EXPERIMENTAL

Sleep Diary

Intervention Type: BEHAVIORAL

Based on the participant's sleep diary data, a new weekly sleep schedule will be prescribed as follows: if sleep efficiency is \<85%, the prescribed time in bed is reduced by 15 minutes (reducing sleep opportunity by 15 minutes); if sleep efficiency is 85-90%, the schedule remains unchanged; if sleep efficiency is \>90%, the prescribed time in bed is increased by 15 minutes, allowing an extra 15 minutes of sleep opportunity.

Intervention: Fitbit

This arm receives weekly feedback on their sleep schedule based on Fitbit data.

Group Type: EXPERIMENTAL

Fitbit

Intervention Type: BEHAVIORAL

Based on the participant's Fitbit data, a new weekly sleep schedule will be prescribed as follows: if sleep efficiency is \<85%, the prescribed time in bed is reduced by 15 minutes (reducing sleep opportunity by 15 minutes); if sleep efficiency is 85-90%, the schedule remains unchanged; if sleep efficiency is \>90%, the prescribed time in bed is increased by 15 minutes, allowing an extra 15 minutes of sleep opportunity.

Interventions

Sleep Diary

Based on the participant's sleep diary data, a new weekly sleep schedule will be prescribed as follows: if sleep efficiency is \<85%, the prescribed time in bed is reduced by 15 minutes (reducing sleep opportunity by 15 minutes); if sleep efficiency is 85-90%, the schedule remains unchanged; if sleep efficiency is \>90%, the prescribed time in bed is increased by 15 minutes, allowing an extra 15 minutes of sleep opportunity.

Intervention Type: BEHAVIORAL

Fitbit

Based on the participant's Fitbit data, a new weekly sleep schedule will be prescribed as follows: if sleep efficiency is \<85%, the prescribed time in bed is reduced by 15 minutes (reducing sleep opportunity by 15 minutes); if sleep efficiency is 85-90%, the schedule remains unchanged; if sleep efficiency is \>90%, the prescribed time in bed is increased by 15 minutes, allowing an extra 15 minutes of sleep opportunity.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Be between the ages of 18-60 years old

2. Have a typical sleep schedule of <=6 hours per night

3. Must have a FitBit device (any model) with Heart Rate Monitor

4. Must have bedtime between 8 pm and 1 am

5. Must have a waketime between 5 am and 10 am

6. Must not have insomnia as determined by diagnosis or score on the Insomnia Severity Index (ISI), or must be treated.

7. Must not have sleep apnea as determined by diagnosis or STOP-BANG scale, or must be treated.

8. Must have a computer or smartphone device for daily sleep diaries.

9. Must have an initial sleep efficiency of at least 85% as determined by sleep diaries and actigraphy.

Exclusion Criteria

1. Any condition that the PI considers would significantly impede participation in the study.

2. Participant is under 18 years of age or older than 60 years of age

3. Does not own a FitBit device with Heart Rate Monitor

4. Sleep >6 hours per night.

5. Typical bedtime before 8 pm or after 1 am

6. Typical waketime before 5 am or after 10 am

7. Diagnosed with sleep disorders including insomnia or sleep apnea

8. Diagnosed mental health disorder which may impact sleep (i.e. Bipolar Disorder)

9. Taking medications that may affect sleep.

10. Baseline sleep efficiency less than 85%.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

MICHAEL A GRANDNER

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A Grandner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dorothy Tung, Bachelors of Science

Role: CONTACT

dorothytung@arizona.edu

480-452-3273

Denisse Armenta

Role: CONTACT

armentamd@arizona.edu

520-626-1737

Other Identifiers

2008934275

Identifier Type: -

Identifier Source: org_study_id