Self Awakening and Snoozing Effects on the Cortisol Awakening Response (SASECAR)
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|ClinicalTrials.gov Identifier: NCT04129593|
Recruitment Status : Not yet recruiting
First Posted : October 17, 2019
Last Update Posted : October 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cortisol Awakening Response||Behavioral: Self Awakening - Natural Waking Behavioral: Snooze - Natural waking||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Participants will undergo 1 of 2 conditions on Saturday and Sunday; Self awakening and natural waking, or snooze and natural waking.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Self Awakening and Snoozing Effects on the Cortisol Awakening Response|
|Estimated Study Start Date :||January 1, 2021|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2023|
Experimental: Self Awakening
Participant will intend to wake up at a specific time before going to bed.
Behavioral: 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.
Participant will set multiple alarms before bed to wake at a specific time.
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.
- Cortisol Awakening Response [ 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. ]A biomarker for Hypothalamic Pituitary Adrenal activity; a naturally occurring increase in cortisol upon waking.
- 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. ]Stress activity before waking can increase heart rate. We want to see if alarms and / or snoozing increase heart rate upon waking
- Sleep inertia - cognitive throughput [ 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129593
|Contact: Stephen M Mattingly, Ph.Demail@example.com|