- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03657901
Sleep, Stress and Learning: an Experimental Pilot Study (Sleepstress)
Study Overview
Status
Intervention / Treatment
Detailed Description
Background Stress and increased alertness in the evening are major reasons for sleep onset problems, poor sleep and insomnia symptoms. For instance, increased amount of REM, and decreased amount of slow wave sleep may result. Also, the function of sleep in memory consolidation may suffer. They also affect the sleep structure and continuity during the night. They are highly prevalent phenomena among the entire population, including healthy adults and children. However, at the physiological level, the concept of evening alertness is still understudied and often neglected.
Recent advances show that breathing exercise is an efficient tool to reduce stress. However, its use specifically prior to sleep onset and with measurement sleep stages and their microstructures with sleep EEG has been little been studied before. The overall objective of this study is to explore interrelations of stress, learning and sleep quality.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland
- University of Helsinki
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 20-45
Exclusion Criteria:
- chronic disease requiring daily medication, acute sickness (e.g. a flu), jet lag from a recent travel, current diagnosed sleep disorder (such as snoring or insomnia) and any use of medication affecting autonomic nervous system function or sleep.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breathing
Guided slow breathing for 30 minutes before sleep onset
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Guided slow breathing for 30 minutes before sleep onset
|
Active Comparator: Music listening
Guided music listening for 30 minutes before sleep onset
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Guided music listening for 30 minutes before sleep onset
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep structure
Time Frame: Change from night 1 to night 2
|
Percent distribution of different sleep stages
|
Change from night 1 to night 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep spindle duration
Time Frame: Change from night 1 to night 2
|
Duration of sleep spindles in seconds
|
Change from night 1 to night 2
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Sleep spindle power
Time Frame: Change from night 1 to night 2
|
Amplitude of sleep spindles in microvolts
|
Change from night 1 to night 2
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anu-Katriina Pesonen, prof, University of Helsinki
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Sleepstress
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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