NCT04129593: SASECAR

Self Awakening and Snoozing Effects on the Cortisol Awakening Response

Status unknown NA Last updated 18 October 2019

What this trial tests

NA trial testing Self Awakening - Natural Waking in Cortisol Awakening Response in 100 participants. Status unknown.

Timeline

1 January 2021

Primary endpoint
1 January 2022

1 January 2023

Quick facts

Lead sponsor	University of Notre Dame
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	100
Start date	1 January 2021
Primary completion	1 January 2022
Estimated completion	1 January 2023

Drugs / interventions tested

• Self Awakening - Natural Waking
• Snooze - Natural waking

Conditions studied

• Cortisol Awakening Response — all drugs for Cortisol Awakening Response →

Sponsor

University of Notre Dame

Who can join

Adults 18 to 65, any sex, with Cortisol Awakening Response. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.