- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04786678
Sensible Sleep: Measuring Alarm and Snooze Behavior in Teens Using Wearables and Smartphones
March 3, 2021 updated by: University of Notre Dame
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:English as a primary language -
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: All participants
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks, daily sleep measured passively via wearable
|
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.
|
12 weeks, Heart rate measured every minute passively via wearable
|
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.
|
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
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.
|
6 weeks via survey. 2 weeks at beginning of study (BASELINE), 2 weeks at beginning of intervention, 2 weeks at end of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2021
Primary Completion (Anticipated)
August 1, 2022
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
March 3, 2021
First Submitted That Met QC Criteria
March 3, 2021
First Posted (Actual)
March 8, 2021
Study Record Updates
Last Update Posted (Actual)
March 8, 2021
Last Update Submitted That Met QC Criteria
March 3, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20-10-6256
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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