Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05728983
Status:
RECRUITING
Last Update Posted:
2023-02-15
First Post:
2023-01-23
Brief Title:
Sleep and Food-based Decision Making
Sponsor:
Appalachian State University
Organization:
Appalachian State University
Study Overview
Official Title:
Insufficient Sleep and Dietary Choices An Ecologically Valid Examination of the Decision Foundations of Eating Behaviors When Sleep Restricted
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study administers two prescribed sleep levels each lasting one week that participants will complete in their at-home environment One week is a well-rested 8-9 hrsnight attempted sleep and another is a sleep-restricted 5-6 hrsnight attempted sleep condition In between these two conditions is an ad lib sleep week At the end of each treatment week the participants come to a laboratory session to go through a series of decision making tasks Participants also track dietary intake through the 3-week protocol using the ASA24 website
This study was fully preregistered on the open science framework OSF has has registration DOI at httpsdoiorg1017605OSFIONSPRK
This study was fully preregistered on the open science framework OSF has has registration DOI at httpsdoiorg1017605OSFIONSPRK
Detailed Description:
THE PRELIMINARY SCREENING SURVEY
This short demographic sleep and mood survey is administered at least twice a year by the investigator Dickinson on random subsets of students at his institution This database survey had been ongoing for several years and has been approved under separate human subjects approval process and has been used by the investigator Dickinson to recruit for a variety of sleep and decision research studies over the years
This short survey provides sufficient information for the investigators to screen out individuals who self-report a sleep disorder who are not within the 18-40 year old target age range for this study who are at significant risk of major depressive or anxiety disorder assessed using validated short-instruments Viable participants who meet the inclusion criterion usually only about 23 of those who complete the survey are randomly assigned to either the control condition or a particular ordering of the treatment condition SR-WR or WR-SR ex ante Afterwards these individuals are invited to participate in the experiment via email note participants are NOT allowed to opt into a condition or treatment ordering to which they were not randomly assigned
THE SLEEP PROTOCOL
The basic sleep protocol will involve recruitment of a total of 130 participants Participants are randomly assigned to the control condition N30 or the treatment condition n100 The investigators anticipate some attrition such that n130 will be enrolled in the study to ultimately obtain n130 participants who will have successfully completed the entire protocol
Both conditions involve 3-weeks of at-home prescribed sleep levels for the participants For the Control participants week 1 prescribes 8-9 hours of attempted sleep per night for the 7 nights of that week refer to this as a well-rested WR week Week 3 for Control participants will be another prescribed WR week
Treatment participants will be prescribed a WR week in week 1 or week 3 and a sleep-restricted SR week 5-6 hrsnight attempted sleep then in week 3 or week 1 That is treatment participants will be administered the treatment conditions either in SR-WR or in WR-SR order counterbalanced across participants For all participants control and treatment week 2 is an ad lib sleep week to wash out the treatment effects of week 1 before commencing the week 3 prescribed sleep level
All participants will complete basic sleep diary records for the entire 3 weeks and will wear a validated sleep-tracking actigraphy device for the duration of the period Objectively measured actigraphy sleep data will be scored using validated protocols
The idea of the 3-week sleep protocol is to obtain within-participants measures of decision-making that will be assessed at the end of weeks 1 and 3 the treatment weeks with the participant in an experimentally manipulated state of well-restedness or chronic partial sleep restriction similar to recommended WR levels and levels of SR common in many adult populations
ADDITIONAL STUDY ELEMENTS In addition to decision making that will be assessed at the end of weeks 1 and 3 of the protocol ie after each experimentally prescribed sleep week participants will also complete daily food recalls of their dietary intake over the course of the 3-week protocol as well as a short form of the International Physical Activity Questionnaire IPAQ and validated measures of cognitive and sleep function at the end of each week of the protocol The IPAQ as well as cognitive and sleep function assessments will be administered online prior to the in-lab decision session at the end of each week all three weeks The daily food recalls will be completed online using the Automated Self-Administered 24-hour dietary assessment tool ASA24
This short demographic sleep and mood survey is administered at least twice a year by the investigator Dickinson on random subsets of students at his institution This database survey had been ongoing for several years and has been approved under separate human subjects approval process and has been used by the investigator Dickinson to recruit for a variety of sleep and decision research studies over the years
This short survey provides sufficient information for the investigators to screen out individuals who self-report a sleep disorder who are not within the 18-40 year old target age range for this study who are at significant risk of major depressive or anxiety disorder assessed using validated short-instruments Viable participants who meet the inclusion criterion usually only about 23 of those who complete the survey are randomly assigned to either the control condition or a particular ordering of the treatment condition SR-WR or WR-SR ex ante Afterwards these individuals are invited to participate in the experiment via email note participants are NOT allowed to opt into a condition or treatment ordering to which they were not randomly assigned
THE SLEEP PROTOCOL
The basic sleep protocol will involve recruitment of a total of 130 participants Participants are randomly assigned to the control condition N30 or the treatment condition n100 The investigators anticipate some attrition such that n130 will be enrolled in the study to ultimately obtain n130 participants who will have successfully completed the entire protocol
Both conditions involve 3-weeks of at-home prescribed sleep levels for the participants For the Control participants week 1 prescribes 8-9 hours of attempted sleep per night for the 7 nights of that week refer to this as a well-rested WR week Week 3 for Control participants will be another prescribed WR week
Treatment participants will be prescribed a WR week in week 1 or week 3 and a sleep-restricted SR week 5-6 hrsnight attempted sleep then in week 3 or week 1 That is treatment participants will be administered the treatment conditions either in SR-WR or in WR-SR order counterbalanced across participants For all participants control and treatment week 2 is an ad lib sleep week to wash out the treatment effects of week 1 before commencing the week 3 prescribed sleep level
All participants will complete basic sleep diary records for the entire 3 weeks and will wear a validated sleep-tracking actigraphy device for the duration of the period Objectively measured actigraphy sleep data will be scored using validated protocols
The idea of the 3-week sleep protocol is to obtain within-participants measures of decision-making that will be assessed at the end of weeks 1 and 3 the treatment weeks with the participant in an experimentally manipulated state of well-restedness or chronic partial sleep restriction similar to recommended WR levels and levels of SR common in many adult populations
ADDITIONAL STUDY ELEMENTS In addition to decision making that will be assessed at the end of weeks 1 and 3 of the protocol ie after each experimentally prescribed sleep week participants will also complete daily food recalls of their dietary intake over the course of the 3-week protocol as well as a short form of the International Physical Activity Questionnaire IPAQ and validated measures of cognitive and sleep function at the end of each week of the protocol The IPAQ as well as cognitive and sleep function assessments will be administered online prior to the in-lab decision session at the end of each week all three weeks The daily food recalls will be completed online using the Automated Self-Administered 24-hour dietary assessment tool ASA24
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None