An interventional study of Accurate Sleep Data Feedback and Inflated Sleep Data Feedback in Sleep, Sleep Quality and Sleepiness, Daytime, sponsored by NextSense, Inc.. Terminated at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by NextSense, Inc. · Not applicable, Interventional, and Health services research
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States — 146 open to participants now, 183 under way, 5 of them phase 3. Sleep Initiation and Maintenance Disorders · United States.
Among the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States, this one is the 534th largest by enrollment of the 855 interventional ones that give a count, is one of 61 that started in 2024, is one of 577 with no phase, and was the 772nd registered.
2,728 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 730 are open to participants now.
Browse Sleep Initiation and Maintenance Disorders studies →146 of the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States are open now. Recruiting first, the newest first:
Florida State University · Sites in United States
Ages 6–13 · Healthy volunteers
University of Pittsburgh · Sites in United States
Ages 65+ · Women only
Eight Sleep Inc. · Sites in United States
Ages 45+ · Healthy volunteers
Proactive Life Inc · Sites in United States
Ages 55+
Spectrum Clinical Research, LLC · Sites in United States
Ages 45–65 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 389 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 207 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: 25 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
903 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 40 · Phase 2 103 · Phase 3 77 · Phase 4 78
First in 1997; this study’s year is marked. 61 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 40 is below the median of 68 across 2,355 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Median enrollment 60 across the 855 interventional studies, 72 across the 48 observational. Of the 660 that completed or were terminated, 243 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
186 of 903 have an industry lead sponsor. The 10 most frequent:
NextSense, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
NextSense, Inc. has 1 study filed under Sleep Initiation and Maintenance Disorders — fewer than ten, so there is no comparison to draw.
79 of the studies in Sleep Initiation and Maintenance Disorders with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568367Phase 3Axsome Therapeutics, Inc.Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) | 2026-12 |
| NCT06655883Phase 3Merck Sharp & Dohme LLCA Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098) | 2027-06-24 |
| NCT07336277Phase 3Emory UniversitySleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients | 2027-07 |
| NCT06953869Phase 3Vanda PharmaceuticalsEvaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia | 2027-11 |
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
Add all 79 to your calendar (.ics) → With an account.
Among the 903 studies in Sleep Initiation and Maintenance Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this clinical trial is to explore how the presentation of sleep data impacts sleep quality, sleep-related behaviors (such as sleepiness), and sleep-related anxiety and stress. The study aims to answer the following key questions:
Participants will:
With the growing prevalence of sleep-tracking wearables available to consumers, understanding the psychological and behavioral impacts they have on users is important. Recent advancements in wearable technology allow for monitoring various sleep parameters, providing users with extensive data on their sleep patterns. The study aims to examine how the presentation of sleep data influences user sleep quality, sleep-related behaviors, including sleepiness, and sleep-related anxiety and stress. It will evaluate how the presentation of sleep data affects individuals\' perceptions of sleep and related health issues, including daytime sleepiness and perceived sleep quality. Participants will receive sleep data feedback based on new methods assessed using Fitbit, brain-sensing earbuds, and other factors that might impact sleep. Additionally, the study seeks to offer valuable insights into sleep research, behavioral psychology, and wearable technology.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey. In this arm, participants will receive accurate feedback about their sleep data.
Behavioral: Accurate Sleep Data Feedback
All arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey. In this arm, participants will receive inflated feedback about their sleep data, suggesting better sleep quality than detected by Fitbit (actual sleep hours +10%).
Behavioral: Inflated Sleep Data Feedback
All arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey. In this arm, participants will receive deflated feedback about their sleep data, suggesting poorer sleep quality than detected by Fitbit (actual sleep hours -10%).
Behavioral: Deflated Sleep Data Feedback
All arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey. In this arm, participants will receive accurate feedback about their sleep data along with sleep-related educational information.
Behavioral: Accurate Sleep Data Feedback + Sleep-related Educational Information
Participants will receive accurate feedback about their sleep data.
Participants will receive inflated feedback about their sleep data, suggesting better sleep quality than detected by Fitbit (actual sleep hours +10%).
Participants will receive deflated feedback about their sleep data, suggesting poorer sleep quality than detected by Fitbit (actual sleep hours -10%).
Participants will receive accurate feedback about their sleep data along with sleep-related educational information.
Participant-reported Sleep Quality
Measured via self-report using the 15-item Groningen Sleep Quality Scale, with scores ranging from 1 to 14. A score of 14 indicates poor sleep quality the previous night.
Time frame: 4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.
Sleep data - Total hours of sleep
Total hours of sleep data tracked by Fitbit
Time frame: 2 weeks (Week 3 - Week 4): measured daily, sleep data tracked by Fitbit will be transmitted to the Alethios platform automatically once a day.
Modified Karolinska Sleepiness Scale
Sleepiness, measured via self-report using the 1-item modified Karolinska Sleepiness Scale, ranges from 1 to 10, with 1 indicating extreme alertness, 3 alert, 5 neither alert nor sleepy, 7 sleepy but no difficulty remaining awake, 9 extremely sleepy, fighting sleep, and 10 extremely sleepy, falling asleep all the time.
Time frame: 4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.
Fitbit tracked Sleep Quality
Fitbit sleep score, ranging from 0 to 100, indicates sleep quality: 90-100 is excellent, 80-89 good, 60-79 fair, and 0-59 poor, based on duration, disturbances, and restorative sleep.
Time frame: 2 weeks (Week 3 - Week 4): measured daily, sleep data tracked by Fitbit will be transmitted to the Alethios platform automatically once a day.
Anxiety, Stress, and Mindset related to Sleep
Measured via self-report using the 7-item survey.
Time frame: 4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
Dysfunctional Beliefs and Attitudes about Sleep 16-item
Sleep-related mindset, measured via self-report using the 16-item Dysfunctional Beliefs and Attitudes about Sleep, involves calculating the average of the scores from all 16 items. Higher average scores indicate a stronger endorsement of sleep-disruptive beliefs, which are considered maladaptive.
Time frame: 4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
Modified Insomnia Severity Index
Severity of Sleep Problems, measured via self-report using the 5-item Insomnia Severity Index, modified to replace Insomnia with Sleep.
Time frame: Week 2 and Week 4: measured twice.
Satisfaction with sleep
Measured via self-report using a single item, with scores ranging from 1 to 5, where 1 indicates very satisfied and 5 indicates very dissatisfied.
Time frame: Week 2 and Week 4: measured twice.
Sleep Problems Interference with Daily Functioning
Measured via self-report using a single item, with scores ranging from 1 to 5, where 1 indicates not at all interfering and 5 indicates very much interfering.
Time frame: Week 2 and Week 4: measured twice.
Pre-Sleep Arousal Scale
Pre-sleep arousal, measured via self-report using the 16-item Pre-Sleep Arousal Scale, with items rated on a 5-point Likert scale from 1 (not at all) to 5 (extremely). The sum of scores from the first 8 items reflects somatic pre-sleep arousal, and the sum of scores from the last 8 items reflects cognitive pre-sleep arousal. Clinically relevant cut-off scores will be used: ≥14 for somatic pre-sleep arousal and ≥20 for cognitive pre-sleep arousal.
Time frame: 4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
Virtual Research Participation
Measured via self-report using the 10-item questionnaire.
Time frame: Once at the end of the study, through study completion, which averages approximately 1 year.
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Feb 2025, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sleep Initiation and Maintenance Disorders →