Metabolic and Cognitive Parameters Following Partial Sleep Deprivation

Sleep Clinical Trial

Official title:

Metabolic and Cognitive Effects of Sleep Deprivation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01823263
• Other study ID #: SleepPartialJCCB2013
• Status: Recruiting
• Phase: N/A
• First received: February 21, 2013
• Last updated: November 27, 2014
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: November 2014
• Source: Uppsala University
• Contact: Jonathan Cedernaes, M.D., PhD
• Email: jonathan.cedernaes[@]neuro.uu.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 28 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sleep
• Sleep Deprivation

Intervention

Behavioral:
• Portion Size 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

Procedure:
• Blood sample
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
• Interference task
30-minute interference task

Behavioral:
• Memory tasks
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.
• Intake task
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
• Working memory function task
Participants will be evaluated on their working memory performance in the morning following either nighttime intervention (NS or PSD)

Locations

Country	Name	City	State
Sweden	Department of Neuroscience, Uppsala University	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)	No
Secondary	Circulating hormone levels	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	No
Secondary	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.	Change in intake at around 1200 hours, following the respective nighttime intervention (NS or PSD)	No
Secondary	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	Change in memory performance at 0800 hours and after the interference task again at 0930 hours (between and following PSD or NS)	No
Secondary	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.	Change in selected portion size from baseline (at 0800 hours following the nighttime intervention), to one hour later, i.e. after an interference task	No