SleepNCT04786678
Sensible Sleep: Measuring Alarm and Snooze Behavior in Teens Using Wearables and Smartphones
A study testing Cell phone notification in people with Sleep and Sleep Inertia, run by University of Notre Dame.
Trial summary
Pilot data suggests that working professionals and college students routinely use alarms and snooze. Alarm usage and snoozing is associated with several negative health biomarkers including lighter sleep, higher resting heart rate, and reduced sleep duration. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Inertia, Stress
- What is being tested?
- Cell phone notification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Sensible Sleep: Measuring Alarm and Snooze Behavior in Teens Using Wearables and Smart Phones
Pilot data suggests that working professionals and college students routinely use alarms and snooze. Alarm usage and snoozing is associated with several negative health biomarkers including lighter sleep, higher resting heart rate, and reduced sleep duration. It is unclear when this behavior is established, but it is likely in the teenage years when chronic sleep restriction begins to effect a large percentage of Americans. We will ask teens about psychological traits (e.g. personality) and snoozing behavior in a repeated measures design. In addition, we will implement a smartphone based intervention which notifies teens when they are awake past their minimum bedtime for adequate sleep. throughout the study, we will monitor sleep and heart-rate via wearable. From this data, we will establish the prevalence of alarm and snoozing behaviors in teens. We will determine what demographic, psychological, and behavioral traits predict snoozing, and if there are any differences in health biomarkers (e.g. sleep duration, resting heart rate)between snooze and/or alarm users. We will use data from the wearables and smartphones to generate features that can detect snoozing, and will validate them against self-report. Finally, we seek to determine if alarm and snoozing behavior can be reduced via a smartphone intervention aimed at increasing sleep duration.
- Conditions
- Sleep, Sleep Inertia, Stress
- Being tested
- Cell phone notification
- Keywords
- Sleep, Sleep Inertia, Caffeine, Sleep Disturbance, Snooze, Alarm
- Medical subject headings
- Idiopathic Hypersomnia, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell phone notificationDevice
Habitual bed and wake times will be detected using a wearable for 4 weeks. Using habitual wake time, a minimum bedtime to achieve adequate sleep will be calculated (8 hours). If phone usage is detected after this minimum bedtime, participants will receive a notification informing them they are awake past their minimum bedtime and recommend they go to bed to obtain adequate sleep.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants will have a baseline before all participants undergo intervention. The purpose is to pilot the intervention to establish possible effects, as well as to determine if there are any usability or other issues. Receives: Device: Cell phone notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Duration
Reduced sleep duration is associated with negative health outcomes. We will compare average baseline and intervention sleep durations (measured by wearables) using 1-way ANCOVA. Covariates will be significant factors from a bivariate logistical regression predicting the proportion of days woken to an alarm or snoozing from total answered survey using demographic, behavioral, psychological, and physiological factors as predictors. If the ANCOVA reveals a significant effect of intervention, a followup ANCOVA will compare average sleep duration for the first two weeks of intervention to the last two weeks of intervention using same covariates to determine if intervention effects change over time. Another follow correlation will compare the number of times the intervention occurred with the average difference of baseline and intervention sleep duration.
Measured: 12 weeks, daily sleep measured passively via wearable
Resting Heart Rate
Higher resting heart rate (RHR) rate is associated with negative health outcomes. We will compare average baseline and intervention RHR (measured by wearables) using 1-way ANCOVA. Covariates will be significant factors from a bivariate logistical regression predicting the proportion of days woken to an alarm or snoozing from total answered survey using demographic, behavioral, psychological, and physiological factors as predictors. If the ANCOVA reveals a significant effect of intervention, a followup ANCOVA will compare average RHR for the first two weeks of intervention to the last two weeks of intervention using same covariates to determine if intervention effects change over time. Another follow correlation will compare the number of times the intervention occurred with the average difference of baseline and intervention RHR.
Measured: 12 weeks, Heart rate measured every minute passively via wearable
Alarm and Snooze Self Report
Alarm and Snoozing (AS) behaviors are associated with negative health outcomes. We will compare average baseline and intervention AS proportions using 1-way ANCOVA. Covariates will be significant factors from a bivariate logistical regression predicting the proportion of days woken to an alarm or snoozing from total answered survey using demographic, behavioral, psychological, and physiological factors as predictors. If the ANCOVA reveals a significant effect of intervention, a followup ANCOVA will compare AS proportion for the first two weeks of intervention to the last two weeks of intervention using same covariates to determine if intervention effects change over time. Another follow correlation will compare the number of times the intervention occurred with the average difference of baseline and intervention AS proportion.
Measured: 6 weeks via survey. 2 weeks at beginning of study (BASELINE), 2 weeks at beginning of intervention, 2 weeks at end of intervention
Reaction Time
Sleep inertia is a cognitive impairment measured using reaction time (RT) following sleep. We will compare average baseline and intervention RTs using 1-way ANCOVA. Covariates will be significant factors from a bivariate logistical regression predicting the proportion of days woken to an alarm or snoozing from total answered survey using demographic, behavioral, psychological, and physiological factors as predictors. If the ANCOVA reveals a significant effect of intervention, a followup ANCOVA will compare RTs for the first two weeks of intervention to the last two weeks of intervention using same covariates to determine if intervention effects change over time. Another follow correlation will compare the number of times the intervention occurred with the average difference of baseline and intervention RTs.
Measured: 6 weeks via survey. 2 weeks at beginning of study (BASELINE), 2 weeks at beginning of intervention, 2 weeks at end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Why it stopped: Study was planned but never initiated by investigator decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be passively monitored for 4 weeks, and all will undergo cell phone based intervention which will notify participants if they are using the cell phone past their latest bedtime for adequate sleep (e.g. if a participant habitually wakes at 8am, and are using their phone past midnight, they will receive a notification).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786678
- Sponsor's protocol ID
- 20-10-6256
- Status last verified
- Jun 2025
- First submitted
- 3 Mar 2021
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensible Sleep: Measuring Alarm and Snooze Behavior in Teens Using Wearables and Smart Phones
- ClinicalTrials.gov ID
- NCT04786678
- Acronym / sponsor ID
- 20-10-6256
- Conditions
- Sleep, Sleep Inertia, Stress
- Keywords
- Sleep, Sleep Inertia, Caffeine, Sleep Disturbance, Snooze, Alarm
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was planned but never initiated by investigator decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 8 Mar 2021 (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.
Pilot data suggests that working professionals and college students routinely use alarms and snooze. Alarm usage and snoozing is associated with several negative health biomarkers including lighter sleep, higher resting heart rate, and reduced sleep duration. It is unclear when this behavior is established, but it is likely in the teenage years when chronic sleep restriction begins to effect a large percentage of Americans. We will ask teens about psychological traits (e.g. personality) and snoozing behavior in a repeated measures design. In addition, we will implement a smartphone based intervention which notifies teens when they are awake past their minimum bedtime for adequate sleep. throughout the study, we will monitor sleep and heart-rate via wearable. From this data, we will establish the prevalence of alarm and snoozing behaviors in teens. We will determine what demographic, psychological, and behavioral traits predict snoozing, and if there are any differences in health biomarkers (e.g. sleep duration, resting heart rate)between snooze and/or alarm users. We will use data from the wearables and smartphones to generate features that can detect snoozing, and will validate them against self-report. Finally, we seek to determine if alarm and snoozing behavior can be reduced via a smartphone intervention aimed at increasing sleep duration.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be passively monitored for 4 weeks, and all will undergo cell phone based intervention which will notify participants if they are using the cell phone past their latest bedtime for adequate sleep (e.g. if a participant habitually wakes at 8am, and are using their phone past midnight, they will receive a notification).
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: Cell phone notificationAll participants will have a baseline before all participants undergo intervention. The purpose is to pilot the intervention to establish possible effects, as well as to determine if there are any usability or other issues. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Cell phone notificationHabitual bed and wake times will be detected using a wearable for 4 weeks. Using habitual wake time, a minimum bedtime to achieve adequate sleep will be calculated (8 hours). If phone usage is detected after this minimum bedtime, participants will receive a notification informing them they are awake past their minimum bedtime and recommend they go to bed to obtain adequate sleep. | Device | All participants |
Primary outcome
Sleep Duration
Time frame: 12 weeks, daily sleep measured passively via wearable
Reduced sleep duration is associated with negative health outcomes. We will compare average baseline and intervention sleep durations (measured by wearables) using 1-way ANCOVA. Covariates will be significant factors from a bivariate logistical regression predicting the proportion of days woken to an alarm or snoozing from total answered survey using demographic, behavioral, psychological, and physiological factors as predictors. If the ANCOVA reveals a significant effect of intervention, a followup ANCOVA will compare average sleep duration for the first two weeks of intervention to the last two weeks of intervention using same covariates to determine if intervention effects change over time. Another follow correlation will compare the number of times the intervention occurred with the average difference of baseline and intervention sleep duration.
Resting Heart Rate
Time frame: 12 weeks, Heart rate measured every minute passively via wearable
Higher resting heart rate (RHR) rate is associated with negative health outcomes. We will compare average baseline and intervention RHR (measured by wearables) using 1-way ANCOVA. Covariates will be significant factors from a bivariate logistical regression predicting the proportion of days woken to an alarm or snoozing from total answered survey using demographic, behavioral, psychological, and physiological factors as predictors. If the ANCOVA reveals a significant effect of intervention, a followup ANCOVA will compare average RHR for the first two weeks of intervention to the last two weeks of intervention using same covariates to determine if intervention effects change over time. Another follow correlation will compare the number of times the intervention occurred with the average difference of baseline and intervention RHR.
Alarm and Snooze Self Report
Time frame: 6 weeks via survey. 2 weeks at beginning of study (BASELINE), 2 weeks at beginning of intervention, 2 weeks at end of intervention
Alarm and Snoozing (AS) behaviors are associated with negative health outcomes. We will compare average baseline and intervention AS proportions using 1-way ANCOVA. Covariates will be significant factors from a bivariate logistical regression predicting the proportion of days woken to an alarm or snoozing from total answered survey using demographic, behavioral, psychological, and physiological factors as predictors. If the ANCOVA reveals a significant effect of intervention, a followup ANCOVA will compare AS proportion for the first two weeks of intervention to the last two weeks of intervention using same covariates to determine if intervention effects change over time. Another follow correlation will compare the number of times the intervention occurred with the average difference of baseline and intervention AS proportion.
Reaction Time
Time frame: 6 weeks via survey. 2 weeks at beginning of study (BASELINE), 2 weeks at beginning of intervention, 2 weeks at end of intervention
Sleep inertia is a cognitive impairment measured using reaction time (RT) following sleep. We will compare average baseline and intervention RTs using 1-way ANCOVA. Covariates will be significant factors from a bivariate logistical regression predicting the proportion of days woken to an alarm or snoozing from total answered survey using demographic, behavioral, psychological, and physiological factors as predictors. If the ANCOVA reveals a significant effect of intervention, a followup ANCOVA will compare RTs for the first two weeks of intervention to the last two weeks of intervention using same covariates to determine if intervention effects change over time. Another follow correlation will compare the number of times the intervention occurred with the average difference of baseline and intervention RTs.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cell phone notification in people with Sleep and Sleep Inertia, run by University of Notre Dame.
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 0 inclusion and 1 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: withdrawn, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Duration (time frame: 12 weeks, daily sleep measured passively via wearable). The study lists 4 primary outcomes in all. 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 15 Jun 2025.