SleepNCT05728983
Sleep and Food-based Decision Making
A study testing Sleep levels in people with Sleep, run by Appalachian State University at 1 site in United States.
Trial 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 hrs/night attempted sleep) and another is a sleep-restricted (5-6 hrs/night attempted sleep) condition. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep levels
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2021to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years of age
Who cannot join
- at risk of major depressive or anxiety disorder (from validated screener), self-reported or suspected sleep disorder, extreme diurnal preference type (from validated screener)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Appalachian State University
Boone, North Carolina, 28608
David Dickinson, 828-262-7652, dickinsondl@appstate.edu
Shante' Mathes, 8282622901, mathessc@appstate.edu
About this study
Official title: Insufficient Sleep and Dietary Choices: An Ecologically Valid Examination of the Decision Foundations of Eating Behaviors When Sleep Restricted
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 hrs/night attempted sleep) and another is a sleep-restricted (5-6 hrs/night 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 https://doi.org/10.17605/OSF.IO/NSPRK
Read the 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 2/3 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 (N=30) or the treatment condition (n=100). The investigators anticipate some attrition such that n>130 will be enrolled in the study to ultimately obtain n=130 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 hrs/night 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 (i.e., 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).
- Conditions
- Sleep
- Being tested
- Sleep levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep levelsOther
Sleep levels are what the experimenter prescribes to participants in the study.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants randomly assigned to the treatment group arm experience both a well-rested and sleep-restricted week during the study Receives: Other: Sleep levels |
| Control group | Placebo comparator | Participants randomly assigned to the treatment group arm experience two well-rested weeks during the study (and they still have an ad lib sleep week in between the two well-rested weeks) Receives: Other: Sleep levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food-Image based go no-go task:
This task is validated in the literature and available in Inquisit programmed form. It assesses inhibitory control in food related image selection (go) or non-selection (no-go) as compared to non-food related images
Measured: 3 weeks
Food-image based Approach Avoidance task
This is a validated task available in Inquisit programmed form and it assess automatic processing to compare one's tendency to approach (pull image towards oneself on computer screen) or avoid (push image away from oneself on computer screen) images reflecting healthier versus less healthy foods
Measured: 3 weeks
Food Choice Task
This task gives participants a short time span (e.g., 10 seconds) to select a set of food images to place in one's onscreen cart. Images includes healthier and unhealthy items.
Measured: 3 weeks
Food preference (ratings) task
This just asks individual to report on a 0-100 scale how much they like various foods based on a displayed image of each (with higher numbers meaning the participant likes the item more)
Measured: 3 weeks
Delay-discounting monetary choice task
This validated task asks one's preference of monetary amounts received today versus larger amounts received at some future point (e.g., 7 days, or 85 days later). Actual choices are paid out for a randomly selected subset of participants on a randomly selected trial (different trials vary the size of the monetary difference and the number of delays for the delayed reward).
Measured: 3 weeks
Food information based confirmation bias task
This task assesses one's tendency to consider arguments regarding the healthiness or tastiness of food as more or less strong based on whether that participants dominant food ideology favors the consideration of healthiness or tastiness of food. The investigators have pilot tested and published a paper on this task.
Measured: 3 weeks
Snack/drink auction task
In this task, participants are given a snack and a beverage as part of a decision session and allowed to bid on how much they would pay (or need to be paid) to exchange their snack or drink for a different snack or drink. Various combinations of snack auctions and drink auctions are considered in order to compare willingness to pay for healthier or less healthy snacks or drinks)
Measured: 3 weeks
Story retelling task
This validated task presents participants with a short story that they are asked to retell so that we can assess preservation of key story details.
Measured: 3 weeks
Dietary intakes
These data are gathered from daily dietary intakes input by participants on the ASA24 dietary recall website, which allows for separation of outcomes by various macronutrients.
Measured: 3 weeks
Secondary outcomes (3)
Psychomotor vigilance task
This validated task assesses reaction time
Measured: 3 weeks
Karolinska sleepiness scale
This validated task assess subjective sleepiness (in the moment). This is assess at Baseline and at the decision sessions that occur during the protocol.
Measured: 3 weeks
Objective Sleep duration
These data are collected from research-grade actigraphy devices worn by the participant.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start2 Sep 2021
- Primary completionApr 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728983
- Sponsor's protocol ID
- SES 2018001
- Status last verified
- Feb 2023
- First submitted
- 23 Jan 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable data are shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insufficient Sleep and Dietary Choices: An Ecologically Valid Examination of the Decision Foundations of Eating Behaviors When Sleep Restricted
- ClinicalTrials.gov ID
- NCT05728983
- Acronym / sponsor ID
- SES 2018001
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 hrs/night attempted sleep) and another is a sleep-restricted (5-6 hrs/night 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 https://doi.org/10.17605/OSF.IO/NSPRK
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 2/3 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 (N=30) or the treatment condition (n=100). The investigators anticipate some attrition such that n>130 will be enrolled in the study to ultimately obtain n=130 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 hrs/night 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 (i.e., 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Sleep levelsParticipants randomly assigned to the treatment group arm experience both a well-rested and sleep-restricted week during the study |
| Control group | Placebo comparator | Other: Sleep levelsParticipants randomly assigned to the treatment group arm experience two well-rested weeks during the study (and they still have an ad lib sleep week in between the two well-rested weeks) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-40 years of age
Key exclusion criteria (1 listed)
- at risk of major depressive or anxiety disorder (from validated screener), self-reported or suspected sleep disorder, extreme diurnal preference type (from validated screener)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep levelsSleep levels are what the experimenter prescribes to participants in the study. | Other | Control group, Treatment group |
Primary outcome
Food-Image based go no-go task:
Time frame: 3 weeks
This task is validated in the literature and available in Inquisit programmed form. It assesses inhibitory control in food related image selection (go) or non-selection (no-go) as compared to non-food related images
Food-image based Approach Avoidance task
Time frame: 3 weeks
This is a validated task available in Inquisit programmed form and it assess automatic processing to compare one's tendency to approach (pull image towards oneself on computer screen) or avoid (push image away from oneself on computer screen) images reflecting healthier versus less healthy foods
Food Choice Task
Time frame: 3 weeks
This task gives participants a short time span (e.g., 10 seconds) to select a set of food images to place in one's onscreen cart. Images includes healthier and unhealthy items.
Food preference (ratings) task
Time frame: 3 weeks
This just asks individual to report on a 0-100 scale how much they like various foods based on a displayed image of each (with higher numbers meaning the participant likes the item more)
Delay-discounting monetary choice task
Time frame: 3 weeks
This validated task asks one's preference of monetary amounts received today versus larger amounts received at some future point (e.g., 7 days, or 85 days later). Actual choices are paid out for a randomly selected subset of participants on a randomly selected trial (different trials vary the size of the monetary difference and the number of delays for the delayed reward).
Food information based confirmation bias task
Time frame: 3 weeks
This task assesses one's tendency to consider arguments regarding the healthiness or tastiness of food as more or less strong based on whether that participants dominant food ideology favors the consideration of healthiness or tastiness of food. The investigators have pilot tested and published a paper on this task.
Snack/drink auction task
Time frame: 3 weeks
In this task, participants are given a snack and a beverage as part of a decision session and allowed to bid on how much they would pay (or need to be paid) to exchange their snack or drink for a different snack or drink. Various combinations of snack auctions and drink auctions are considered in order to compare willingness to pay for healthier or less healthy snacks or drinks)
Story retelling task
Time frame: 3 weeks
This validated task presents participants with a short story that they are asked to retell so that we can assess preservation of key story details.
Dietary intakes
Time frame: 3 weeks
These data are gathered from daily dietary intakes input by participants on the ASA24 dietary recall website, which allows for separation of outcomes by various macronutrients.
3 secondary outcomes
Psychomotor vigilance task
Time frame: 3 weeks
Karolinska sleepiness scale
Time frame: 3 weeks
Objective Sleep duration
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No. No identifiable data are shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep levels in people with Sleep, run by Appalachian State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food-Image based go no-go task: (time frame: 3 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.