CClinicalTrials.gg
Status unknownNCT04129593SASECARUpdated Oct 18, 2019

Self Awakening and Snoozing Effects on the Cortisol Awakening Response

An interventional study of Self Awakening - Natural Waking and Snooze - Natural waking in Cortisol Awakening Response, sponsored by University of Notre Dame. Status unknown. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-18.

Sponsored by University of Notre Dame · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

One third of American adults and teens are sleep deprived, and less than 8% of highschool students achieve recommended amounts of sleep. 85% of Americans consume caffeine daily, and a pilot study we conducted suggests over half of working professionals snooze. Sleep deprivation results in sleep inertia (grogginess) upon waking, and many behaviors are employed to reduce the negative effects of sleep inertia, including self-awakening (SA - going to bed intending to wake at a specific time) and snoozing (setting multiple alarms or using a snooze function). SA reduces sleep inertia and may increase stress system activity before waking, but snoozing is virtually unstudied, though alarms can also increase stress system activity. The cortisol awakening response (CAR) is a boost in the stress hormone, cortisol, that occurs naturally upon waking. The CAR is thought to reduce sleep inertia and to prepare for the anticipated stressors of the day, and this physiological process can be blunted in those who are sleep deprived and/or have medical or psychiatric conditions. This proposal seeks to increase the CAR in healthy individuals through SA and snooze interventions. Participants receive a commercial wearable at the beginning of the week that tracks sleep and heart rate, as well as a study phone that monitors the sleep environment, tracks alarms, and administers cognitive tests after waking to determine sleep inertia. These devices allow a development of baseline waking behavior. On Saturday and Sunday mornings undergo additional including a higher quality heart rate monitor and body temperature sensor. Participants also undergo 2 of 3 conditions; SA, snoozing, and natural waking. In the SA condition, participants intend to wake up 7 hours after they go to bed. In the snooze condition, participants set multiple alarms to terminate 7 hours after bedtime. In the natural waking condition, participants wake up normally. Upon waking, participants provide multiple saliva samples and undergo cognitive performance assessments and answer questions about mood for 1 hour. By comparing the cortisol samples between conditions, we can determine if SA and/or snoozing increases the CAR relative to natural waking. The cognitive performance tests will also be tested between conditions to determine if the interventions reduce sleep inertia and/or increase stress system activity. Interventions that specifically increase the CAR and reduce sleep inertia in healthy individuals could then be tested for those who have blunted CAR, e.g. chronic pain sufferers, to improve quality of life.

02

Conditions studied

  • Cortisol Awakening Response
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In context

Lead sponsor

University of Notre Dame is the lead sponsor of 28 studies on the registry; 9 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Legally able to provide consent -

Exclusion criteria

Exclusion Criteria:

Not legally able to provide consent

-

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Self Awakening

    Participant will intend to wake up at a specific time before going to bed.

    Behavioral: Self Awakening - Natural Waking

  • Experimental
    Snooze

    Participant will set multiple alarms before bed to wake at a specific time.

    Behavioral: Snooze - Natural waking

Interventions

  • BehavioralSelf Awakening - Natural Waking

    subjects in this arm will be assigned to natural waking and self awaking conditions on Saturday and Sunday. they will be counterbalanced equally between Saturday: natural waking, Sunday: self awakening and Saturday: self awakening, Sunday: natural waking.

  • BehavioralSnooze - Natural waking

    subjects in this arm will be assigned to snooze and natural waking conditions on Saturday and Sunday. they will be counterbalanced equally between Saturday: snooze, Sunday: natural waking and Saturday: natural waking, Sunday: snooze.

06

What researchers measure

Primary outcomes

  1. Cortisol Awakening Response

    A biomarker for Hypothalamic Pituitary Adrenal activity; a naturally occurring increase in cortisol upon waking.

    Time frame: 4 samples: immediately upon waking, 15 minutes post waking, 30 minutes post waking, and 45 minutes post waking. Samples are provided for 10 minutes.

Secondary outcomes

  1. Heart Rate upon waking

    Stress activity before waking can increase heart rate. We want to see if alarms and / or snoozing increase heart rate upon waking

    Time frame: Heart rate will be continuously assessed for the entire week. Note: data is divided into 1 minute bin averages.

  2. Sleep inertia - cognitive throughput

    sleep inertia is a marked decrease in cognitive abilities upon waking. We wish to see if cognitive performance upon waking is better when snoozing or self awakening.

    Time frame: During weekdays, sleep inertia will be assessed immediately upon waking, duration is 5 minutes. On Saturday and Sunday, they will be assessed at wake + 10 minutes, wake +25 minutes, wake + 40 minutes, and wake + 55minutes.

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04129593
Lead sponsor
University of Notre Dame
Responsible party
Stephen Mattingly (Post-Doctoral Reserarcher, University of Notre Dame) — Principal investigator
First posted
Oct 17, 2019
Start date
Jan 1, 2021 (estimated)
Primary completion
Jan 1, 2022 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Oct 18, 2019

Study contacts

Stephen M Mattingly, Ph.D
Contact
smattin1@nd.edu
5135824691

Oversight

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

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This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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