Sensible Sleep: Measuring Alarm and Snooze Behavior in Teens Using Wearables and Smartphones

Stress Clinical Trial

Official title:

Sensible Sleep: Measuring Alarm and Snooze Behavior in Teens Using Wearables and Smart Phones

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04786678
• Other study ID #: 20-10-6256
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2021
• Source: University of Notre Dame
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:English as a primary language - Exclusion Criteria: -

Related Conditions & MeSH terms

• Sleep
• Sleep Inertia
• Stress

Intervention

Behavioral:
• Cell phone notification
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Notre Dame

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks, daily sleep measured passively via wearable
Primary	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.	12 weeks, Heart rate measured every minute passively via wearable
Primary	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.	6 weeks via survey. 2 weeks at beginning of study (BASELINE), 2 weeks at beginning of intervention, 2 weeks at end of intervention
Primary	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.	6 weeks via survey. 2 weeks at beginning of study (BASELINE), 2 weeks at beginning of intervention, 2 weeks at end of intervention