NCT07345767

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,038

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Mar 2026May 2027

First Submitted

Initial submission to the registry

January 7, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

January 7, 2026

Last Update Submit

February 11, 2026

Conditions

Short Sleep Duration

Outcome Measures

Primary Outcomes (1)

  • Sleep Duration

    Measured in minutes. It is trended from enrollment until the end of the study

    9 weeks from enrollment to the end of the study

Secondary Outcomes (3)

  • Sleepiness/Fatigue

    9 weeks from enrollment to end of the study

  • Mental Health

    9 weeks from enrollment to the end of the study

  • Cognitive Functioning

    9 weeks from enrollment to the end of the study

Study Arms (3)

Control

NO INTERVENTION

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.

Intervention: Sleep Diary

EXPERIMENTAL

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

Behavioral: Sleep Diary

Intervention: Fitbit

EXPERIMENTAL

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

Behavioral: Fitbit

Interventions

Sleep DiaryBEHAVIORAL

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: Sleep Diary
FitbitBEHAVIORAL

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: Fitbit

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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
  • Must have a FitBit device (any model) with Heart Rate Monitor
  • Must have bedtime between 8 pm and 1 am
  • Must have a waketime between 5 am and 10 am
  • Must not have insomnia as determined by diagnosis or score on the Insomnia Severity Index (ISI), or must be treated.
  • Must not have sleep apnea as determined by diagnosis or STOP-BANG scale, or must be treated.
  • Must have a computer or smartphone device for daily sleep diaries.
  • Must have an initial sleep efficiency of at least 85% as determined by sleep diaries and actigraphy.

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
  • Does not own a FitBit device with Heart Rate Monitor
  • Sleep \>6 hours per night.
  • Typical bedtime before 8 pm or after 1 am
  • Typical waketime before 5 am or after 10 am
  • Diagnosed with sleep disorders including insomnia or sleep apnea
  • Diagnosed mental health disorder which may impact sleep (i.e. Bipolar Disorder)
  • Taking medications that may affect sleep.
  • Baseline sleep efficiency less than 85%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85719, United States

RECRUITING

Study Officials

  • Michael A Grandner, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorothy Tung, Bachelors of Science

CONTACT

480-452-3273dorothytung@arizona.edu

Denisse Armenta

CONTACT

520-626-1737armentamd@arizona.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 16, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

US(1)