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Metabolic and Cognitive Parameters Following Partial Sleep Deprivation

Primary Purpose

Sleep Deprivation, Sleep

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Portion Size Task
Blood sample
Interference task
Memory tasks
Intake task
Working memory function task
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Deprivation

Eligibility Criteria

20 Years - 28 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Neuroscience, Uppsala UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Partial sleep deprivation

Normal sleep

Arm Description

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'.

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'.

Outcomes

Primary Outcome Measures

Memory tasks
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.

Secondary Outcome Measures

Circulating hormone levels
Interference task given at 0900 hours
Intake task
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.
Working memory function task
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
Portion Size 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.

Full Information

First Posted
February 21, 2013
Last Updated
November 27, 2014
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT01823263
Brief Title
Metabolic and Cognitive Parameters Following Partial Sleep Deprivation
Official Title
Metabolic and Cognitive Effects of Sleep Deprivation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation, Sleep

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Partial sleep deprivation
Arm Type
Experimental
Arm Description
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'.
Arm Title
Normal sleep
Arm Type
Experimental
Arm Description
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'.
Intervention Type
Behavioral
Intervention Name(s)
Portion Size Task
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Interference task
Intervention Description
30-minute interference task
Intervention Type
Behavioral
Intervention Name(s)
Memory tasks
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intake task
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Working memory function task
Intervention Description
Participants will be evaluated on their working memory performance in the morning following either nighttime intervention (NS or PSD)
Primary Outcome Measure Information:
Title
Memory tasks
Description
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.
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)
Secondary Outcome Measure Information:
Title
Circulating hormone levels
Description
Interference task given at 0900 hours
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
Title
Intake task
Description
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.
Time Frame
Change in intake at around 1200 hours, following the respective nighttime intervention (NS or PSD)
Title
Working memory function task
Description
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
Time Frame
Change in memory performance at 0800 hours and after the interference task again at 0930 hours (between and following PSD or NS)
Title
Portion Size Task
Description
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.
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Cedernaes, M.D., PhD
Email
jonathan.cedernaes@neuro.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Benedict, PhD
Email
christian.benedict@neuro.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Benedict, PhD
Organizational Affiliation
Department of Neuroscience, Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neuroscience, Uppsala University
City
Uppsala
ZIP/Postal Code
75105
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Cedernaes, M.D, PhD
First Name & Middle Initial & Last Name & Degree
Christian Benedict, PhD
First Name & Middle Initial & Last Name & Degree
Christian Benedict, PhD

12. IPD Sharing Statement

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Metabolic and Cognitive Parameters Following Partial Sleep Deprivation

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