Registration of Skin-Temperatures and Sleep-Wake Behaviour
NCT ID: NCT00319371
Last Updated: 2008-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2005-11-30
2006-06-30
Brief Summary
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This project will provide further information at which circadian phase vasospasms occur in daily routine life (one week recordings). Special interest lays on the time before sleep. The attained results could be used to establish a therapy with few side effects for people with difficulties initiating sleep because of vasospasm.
Detailed Description
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20 women with vasospasm and difficulties of initiating sleep and 20 women without vasospasm and no difficulties of initiating sleep.
Women without contraceptives will be examined in the luteal phase (i.e. in the two weeks before menstruation). The ambulant registry will be done continuously during one week with so called i-Buttons (IButtonTM, Maxim, USA). These will be fixed to various parts of the body (i.e. wrist, ankle, …) with Fixomull, a medical bond. Also the subjects have to wear a instrument for registration activity, the so called Actiwatch (Cambridge, UK). The data that will be gained from these instruments, shall help us to objectify sleep-latency and sleep-fragmentation ("sleeping-through").
Furthermore, the subjects obtain a sleep-and activity-dairy, that has to be filled before and after sleeping. At one day, that the proband can choose, saliva samples have to be taken by the subjects themselves. In the saliva, the concentration of melatonin will be qualified. The attained results could be used to establish a therapy with few side effects for people with difficulties of initiating sleep because of vasospasm.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1
women with vasospasm and difficulties of initiating sleep
No interventions assigned to this group
2
women without vasospasm and no difficulties of initiating sleep
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Controls have to show no vasospasm and no difficulties of initiating sleep (screening with questionnaires and interview)
Exclusion Criteria
* allergies (i.e. nickel)
* medication
* BMI\<18
* migraine
* delayed sleep phase syndrome
* advanced sleep phase syndrome
* alcohol- or drug problems
* smokers
* blood donation in last three months before study
* participation at an other clinical study in last three months before study
* shift work in last three months before study
* long-distance flight (\> 2 time zones) in last month before study
20 Years
40 Years
FEMALE
Yes
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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University Hospital, Basel, Switzerland
Principal Investigators
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Selim Orgül, MD
Role: STUDY_DIRECTOR
University Eye Clinic Basel
Locations
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University Eye Clinic Basel
Basel, Canton of Basel-City, Switzerland
Countries
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Related Links
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Related Info
Related Info
Other Identifiers
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02/06
Identifier Type: -
Identifier Source: secondary_id
074-GOB-2006-001
Identifier Type: -
Identifier Source: org_study_id