Short Sleep DurationNCT07345767
Hypknowledge Nationwide Sleep Extension
A study testing Sleep Diary and Fitbit in people with Short Sleep Duration, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Short Sleep Duration
- What is being tested?
- Sleep Diary and Fitbit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,038 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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%.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 85719
About this study
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.
Read the 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
- Being tested
- Sleep Diary, Fitbit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep DiaryBehavioural
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.
FitbitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep Diary |
| Intervention: Fitbit | Experimental | This arm receives weekly feedback on their sleep schedule based on Fitbit data. Receives: Behavioral: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Duration
Measured in minutes. It is trended from enrollment until the end of the study
Measured: 9 weeks from enrollment to the end of the study
Secondary outcomes (3)
Sleepiness/Fatigue
Assessed pre and post-study using questionnaires
Measured: 9 weeks from enrollment to end of the study
Mental Health
Assessed pre and post-study using questionnaires
Measured: 9 weeks from enrollment to the end of the study
Cognitive Functioning
Assessed pre and post-study using questionnaires
Measured: 9 weeks from enrollment to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Sleep DurationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,038 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MICHAEL A GRANDNER, University of Arizona
- Investigators
- Michael A Grandner, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345767
- Sponsor's protocol ID
- 2008934275
- Status last verified
- May 2026
- First submitted
- 7 Jan 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypknowledge Nationwide Sleep Extension
- ClinicalTrials.gov ID
- NCT07345767
- Acronym / sponsor ID
- 2008934275
- Conditions
- Short Sleep Duration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,038 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Sleep DiaryThis arm receives weekly feedback on their sleep schedule based on sleep diary data. |
| Intervention: Fitbit | Experimental | Behavioral: FitbitThis arm receives weekly feedback on their sleep schedule based on Fitbit data. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep DiaryBased 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. | Behavioural | Intervention: Sleep Diary |
| FitbitBased 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. | Behavioural | Intervention: Fitbit |
Primary outcome
Sleep Duration
Time frame: 9 weeks from enrollment to the end of the study
Measured in minutes. It is trended from enrollment until the end of the study
3 secondary outcomes
Sleepiness/Fatigue
Time frame: 9 weeks from enrollment to end of the study
Mental Health
Time frame: 9 weeks from enrollment to the end of the study
Cognitive Functioning
Time frame: 9 weeks from enrollment to the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael A Grandner, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Diary and Fitbit in people with Short Sleep Duration, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annie Chen, Bachelors of Science (520-621-5850, sleeptechstudy@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Duration (time frame: 9 weeks from enrollment to the end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.