ClinicalTrials.gg
CompletedNCT07889466LS4Updated Oct 23, 2026

Circadian-informed Optimal Bedtime

An interventional study of Optimal Bedtime and Placebo in Sleep, Alertness, Fatigue, Mood, and Performance and Well-being, sponsored by Massachusetts Institute of Technology. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Massachusetts Institute of Technology · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jun 2025, registered Oct 2026).
Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
203
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The goal of this interventional study is to test whether circadian-informed bedtime recommendations can improve sleep, next-day psychomotor vigilance, and subjective well-being among healthy adults. The main questions it aims to answer are:

  • Can Optimal Bedtime derived from data collected by a consumer smartwatch increase the objective total sleep time?
  • Can Optimal Bedtime derived from data collected by a consumer smartwatch reduce the count of lapse in a next-day Psychomotor Vigilance Task?
  • Can Optimal Bedtime derived from data collected by a consumer smartwatch increase subjective sleep quality?

Researchers will compare Optimal Bedtime with a placebo bedtime and an unguided baseline in a cross-over design.

Participants will:

  • Be randomized 1:1 to either Optimal Bedtime then placebo or placebo then Optimal Bedtime.
  • Wear a consumer smartwatch for 6 weeks, 2 weeks in each of baseline, Optimal Bedtime, and placebo.
  • Complete a Psychomotor Vigilance Task and a subjective well-being survey every morning.
02

Conditions studied

  • Sleep
  • Alertness, Fatigue, Mood, and Performance
  • Well-being

Browse trials for

03

In context

Fatigue

1,912 studies on the registry are indexed under Fatigue; 381 are open to participants now.

This study's enrollment of 203 is above the median of 53 across 1,479 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Massachusetts Institute of Technology is the lead sponsor of 34 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 to 60
  • English-speaking
  • Residence of the U.S.
  • Owner of a Samsung Galaxy Watch paired with an Android phone

Exclusion criteria

Exclusion Criteria:

  • Shift work schedule
  • Current smoker or currently using recreational drug
  • Diagnosis of any sleep or circadian rhythm disorder
  • Currently taking medications that may inhibit melatonin production
  • History of traumatic brain injury, stroke, or seizure
  • Plan of traveling across time zones during the study
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
203 participants (actual)

Study arms

  • Other
    Optimal Bedtime then placebo

    Optimal Bedtime recommendation for two weeks followed by placebo bedtime recommendation for two weeks (randomized crossover)

    Behavioral: Optimal Bedtime · Behavioral: Placebo

  • Other
    Placebo then Optimal Bedtime

    Placebo bedtime recommendation for two weeks followed by Optimal Bedtime recommendation for two weeks (randomized crossover)

    Behavioral: Optimal Bedtime · Behavioral: Placebo

Interventions

  • BehavioralOptimal Bedtime

    Optimal Bedtime recommendations informed by the estimated dim-light melatonin onset from a consumer smartwatch, adjusted for the desired total sleep time of the participant and delivered via a mobile application twice a day.

    Also known as: Smart Bedtime

  • BehavioralPlacebo

    Placebo bedtime recommendations based on the desired total sleep time and desired wake-up time of the participant with a daily random jitter within ± 30 minutes, delivered via a mobile application twice a day.

06

What researchers measure

Primary outcomes

  1. Change from Baseline and Placebo in Total Sleep Time

    Smartwatch-derived objective total sleep time in minutes.

    Time frame: 6 weeks, nightly in baseline, placebo, and intervention.

  2. Change from Baseline and Placebo in the Count of Lapse in Psychomotor Vigilance Task (PVT)

    Count of responses with reaction time greater than 500 milliseconds in a PVT session.

    Time frame: 6 weeks, daily in baseline, placebo, and intervention.

  3. Change from Baseline and Placebo in Subjective Sleep Quality

    Self-reported sleep quality score on a visual analogue scale of 0 to 100, higher indicating more favorable.

    Time frame: 6 weeks, daily in baseline, placebo, and intervention.

Secondary outcomes

  1. Change from Baseline and Placebo in Sleep Efficiency

    Objective total sleep time divided by time in bed, in percentage points.

    Time frame: 6 weeks, nightly in baseline, placebo, and intervention.

  2. Change from Baseline and Placebo in Sleep Fragmentation Index

    Waking bouts per 100 min of objective total sleep time.

    Time frame: 6 weeks, nightly in baseline, placebo, and intervention.

  3. Change from Baseline and Placebo in Wake After Sleep Onset

    Objective total time awake after sleep onset and before wake onset, in minutes.

    Time frame: 6 weeks, nightly in baseline, placebo, and intervention.

  4. Change from Baseline and Placebo in Deep Sleep Duration

    Smartwatch-derived deep sleep duration in minutes.

    Time frame: 6 weeks, nightly in baseline, placebo, and intervention.

  5. Change from Baseline and Placebo in Deep Sleep Percentage

    Smartwatch-derived deep sleep in percentage of objective total sleep time.

    Time frame: 6 weeks, nightly in baseline, placebo, and intervention.

  6. Change from Baseline and Placebo in Rapid Eye Movement (REM) Sleep Duration

    Smartwatch-derived REM sleep duration in minutes.

    Time frame: 6 weeks, nightly in baseline, placebo, and intervention.

  7. Change from Baseline and Placebo in Rapid Eye Movement (REM) Sleep Percentage

    Smartwatch-derived REM sleep in percentage of objective total sleep time.

    Time frame: 6 weeks, nightly in baseline, placebo, and intervention.

  8. Change from Baseline and Placebo in Mean Response Speed

    Mean reciprocal reaction time in a PVT session, in per second.

    Time frame: 6 weeks, daily in baseline, placebo, and intervention.

  9. Change from Baseline and Placebo in Mean Slowest-10% Response Speed

    Mean reciprocal reaction time over the slowest 10% responses in a PVT session, in per second.

    Time frame: 6 week, daily in baseline, placebo, and intervention.

  10. Change from Baseline and Placebo in Subjective Alertness

    Daily self-reported alertness score on a visual analogue scale of 0 to 100, higher indicating more favorable.

    Time frame: 6 weeks, daily in baseline, placebo, and intervention.

  11. Change from Baseline and Placebo in Subjective Happiness

    Self-reported happiness score on a visual analogue scale of 0 to 100, higher indicating more favorable.

    Time frame: 6 weeks, daily in baseline, placebo, and intervention.

  12. Change from Baseline and Placebo in Subjective Energy

    Self-reported energy score on a visual analogue scale of 0 to 100, higher indicating more favorable.

    Time frame: 6 weeks, daily in baseline, placebo, and intervention.

  13. Change from Baseline and Placebo in Subjective Health

    Self-reported health score on a visual analogue scale of 0 to 100, higher indicating more favorable.

    Time frame: 6 weeks, daily in baseline, placebo, and intervention.

  14. Change from Baseline and Placebo in Subjective Calmness

    Self-reported calmness score on a visual analogue scale of 0 to 100, higher indicating more favorable.

    Time frame: 6 weeks, daily in baseline, placebo, and intervention.

07

Study locations

1 site
  • Massachusetts Institute of Technology
    Cambridge, Massachusetts 02139, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2025 to primary completion in Jan 2026, 7 months.

Of 771 non-industry interventional studies with no phase under Fatigue, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 7 months is below that.

Counting every sponsor, half of 824 studies reached it within 12 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2026
First posted
Oct 22, 2026
StartActual
Jun 11, 2025
Primary completionActual
Jan 30, 2026
CompletionActual
Jan 30, 2026
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07889466
Lead sponsor
Massachusetts Institute of Technology
Collaborators
Samsung Research America
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Jun 11, 2025
Primary completion
Jan 30, 2026
Completion
Jan 30, 2026
Last update
Oct 23, 2026

Study contacts

Rosalind W Picard, Sc. D.
principal investigator · Massachusetts Institute of Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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