- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01823263
Metabolic and Cognitive Parameters Following Partial Sleep Deprivation
November 27, 2014 updated by: Uppsala University
Metabolic and Cognitive Effects of Sleep Deprivation
The purpose of this study is to determine whether partial sleep deprivation, as compared with normal sleep, influences certain metabolic and cognitive parameters, related to food intake, hunger and memory functions, when participants are shielded from external time cues.
Study Overview
Status
Unknown
Conditions
Detailed Description
It is predicted that partial sleep deprivation negatively affects the hormonal status, e.g.
upregulating ghrelin and other hunger-promoting hunger hormones, while showing impaired memory functions.
It is also predicted that participants will tend to increase their desired portion sizes after partial sleep deprivation, compared with after a normal night's sleep.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jonathan Cedernaes, M.D., PhD
- Email: jonathan.cedernaes@neuro.uu.se
Study Contact Backup
- Name: Christian Benedict, PhD
- Email: christian.benedict@neuro.uu.se
Study Locations
-
-
-
Uppsala, Sweden, 75105
- Recruiting
- Department of Neuroscience, Uppsala University
-
Contact:
- Jonathan Cedernaes, M.D, PhD
-
Contact:
- Christian Benedict, PhD
-
Principal Investigator:
- Christian Benedict, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 28 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- Age 20-28y
- Healthy (self-reported) and not on medication
- Non-smoking
- Normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported and verified by sleep diaries)
- Normal dietary habits (regular meal pattern with daily breakfast)
Exclusion Criteria:
- Major illness
- Taking any serious medications
- Any sleep conditions (e.g. irregular bedtimes, sleep complaints)
- Any dietary issues with the food items provided
- A history of endocrine, neurological or psychiatric disorders
- Shift work in the previous 3 months
- Travel over several time zones within the previous two months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Partial sleep deprivation
Partial sleep deprivation: participants will have a 4-h sleep opportunity before a 'Blood Sample' will be taken, and the 'Memory tasks', 'Working memory function task' and 'Portion size task' will be performed.
This will be followed by an 'Interference task', followed by repeated blood sampling and an 'Intake task'.
|
Participants are given a computer program that gives them the opportunity to choose the portions of a variety of food items that they would ideally like to consume
In the morning following partial sleep deprivation or normal sleep, a blood sample will be taken to assess the level of metabolism-linked and neurodegenerative-linked molecules, as well as to assay blood serum and plasma for the presence of hormones involved in hunger such as ghrelin
30-minute interference task
Participants will be allowed to learn a procedural memory task before going to bed.
Participants will be retested in the morning to assess their change in performance.
Other memory tests will also be given to assess the working memory performance in the morning following the intervention.
After a normal night of sleep or partial sleep deprivation, participants are presented with an ad libitum meal choice and can select the amount to ingest during a limited time window.
Amount and selection will be recorded
Participants will be evaluated on their working memory performance in the morning following either nighttime intervention (NS or PSD)
|
Experimental: Normal sleep
Normal sleep: participants will have an 8-h sleep opportunity before a 'Blood Sample' will be taken, and the 'Memory tasks', 'Working memory function task' and 'Portion size task' will be performed.
This will be followed by an 'Interference task', followed with repeated blood sampling and an 'Intake task'.
|
Participants are given a computer program that gives them the opportunity to choose the portions of a variety of food items that they would ideally like to consume
In the morning following partial sleep deprivation or normal sleep, a blood sample will be taken to assess the level of metabolism-linked and neurodegenerative-linked molecules, as well as to assay blood serum and plasma for the presence of hormones involved in hunger such as ghrelin
30-minute interference task
Participants will be allowed to learn a procedural memory task before going to bed.
Participants will be retested in the morning to assess their change in performance.
Other memory tests will also be given to assess the working memory performance in the morning following the intervention.
After a normal night of sleep or partial sleep deprivation, participants are presented with an ad libitum meal choice and can select the amount to ingest during a limited time window.
Amount and selection will be recorded
Participants will be evaluated on their working memory performance in the morning following either nighttime intervention (NS or PSD)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Memory tasks
Time Frame: Change in memory performance between learning (at 2230 hours in NS and PSD condition) before going to sleep, and at 0800 and 0930 hours (following PSD or NS)
|
Procedural memory performance after learning a procedural memory task close to going to bed, followed by either partial sleep deprivation (PSD) or normal sleep (NS), and comparing the performance the following morning at two time points.
Participants spatial memory performance in the morning at two time points, following PSD will also be compared with that following NS, after having learned such a memory task in the evening before going to bed.
|
Change in memory performance between learning (at 2230 hours in NS and PSD condition) before going to sleep, and at 0800 and 0930 hours (following PSD or NS)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circulating hormone levels
Time Frame: Change in circulating hormone levels and other metabolism-linked and neurodegeneration-associated molecules at 0730, 0830, 0910, 0925, 0940, 1010, 1040, 1105, and 1150 hours following the respective nighttime intervention and after the interference task
|
Interference task given at 0900 hours
|
Change in circulating hormone levels and other metabolism-linked and neurodegeneration-associated molecules at 0730, 0830, 0910, 0925, 0940, 1010, 1040, 1105, and 1150 hours following the respective nighttime intervention and after the interference task
|
Intake task
Time Frame: Change in intake at around 1200 hours, following the respective nighttime intervention (NS or PSD)
|
Participants are presented with an ad libitum meal choice and can select the amount to ingest during a limited time window.
Amount and selection will be recorded.
|
Change in intake at around 1200 hours, following the respective nighttime intervention (NS or PSD)
|
Working memory function task
Time Frame: Change in memory performance at 0800 hours and after the interference task again at 0930 hours (between and following PSD or NS)
|
Participants will be evaluated on their working memory performance in the morning following either nighttime intervention (NS or PSD) and before and after an interference task
|
Change in memory performance at 0800 hours and after the interference task again at 0930 hours (between and following PSD or NS)
|
Portion Size Task
Time Frame: Change in selected portion size from baseline (at 0800 hours following the nighttime intervention), to one hour later, i.e. after an interference task
|
Participants will be evaluated on their tendency to choose larger or smaller portions of a variety of meal items on a computer screen.
This will be conducted both following partial sleep deprivation and normal sleep, and changes before and after a short interference task will be compared between these two conditions.
|
Change in selected portion size from baseline (at 0800 hours following the nighttime intervention), to one hour later, i.e. after an interference task
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Benedict, PhD, Department of Neuroscience, Uppsala University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Anticipated)
March 1, 2015
Study Completion (Anticipated)
March 1, 2015
Study Registration Dates
First Submitted
February 21, 2013
First Submitted That Met QC Criteria
March 28, 2013
First Posted (Estimate)
April 4, 2013
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
November 27, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SleepPartialJCCB2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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