Self Awakening and Snoozing Effects on the Cortisol Awakening Response

NCT ID: NCT04129593

Last Updated: 2019-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cortisol Awakening Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will undergo 1 of 2 conditions on Saturday and Sunday; Self awakening and natural waking, or snooze and natural waking.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Self Awakening

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

Group Type EXPERIMENTAL

Self Awakening - Natural Waking

Intervention Type BEHAVIORAL

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.

Snooze

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

Group Type EXPERIMENTAL

Snooze - Natural waking

Intervention Type BEHAVIORAL

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.

Interventions

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Self 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.

Intervention Type BEHAVIORAL

Snooze - 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Legally able to provide consent -

Exclusion Criteria

Not legally able to provide consent

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Notre Dame

OTHER

Sponsor Role lead

Responsible Party

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Stephen Mattingly

Post-Doctoral Reserarcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Stephen M Mattingly, Ph.D

Role: CONTACT

5135824691

Other Identifiers

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19-08-5534

Identifier Type: -

Identifier Source: org_study_id

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