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Registration of Skin-Temperatures and Sleep-Wake Behaviour

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00319371
First received: April 4, 2006
Last updated: September 25, 2008
Last verified: September 2008
History of Changes

April 4, 2006
September 25, 2008
November 2005
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Complete list of historical versions of study NCT00319371 on ClinicalTrials.gov Archive Site
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Registration of Skin-Temperatures and Sleep-Wake Behaviour
Registration of Skin-Temperatures and Sleep-Wake Behaviour in the Daily Life of Women With Vasospasm in Comparison to Controls

We study the skin-temperature (skin temperature measurement on different skin regions) and circadian rest-activity cycles (wrist activity monitoring) of 40 women in their daily life.

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.

We study the skin-temperature and circadian rest-activity cycles of 40 women in their daily life.

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

women with vasospasm and difficulties of initiating sleep and women without vasospasm and no difficulties of initiating sleep
Vasospastic Syndrome
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  • 1
    women with vasospasm and difficulties of initiating sleep
  • 2
    women without vasospasm and no difficulties of initiating sleep
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2006
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Inclusion Criteria:

  • Subjects have to show a vasospasm and difficulties of initiating sleep (screening with questionnaires and interview)
  • Controls have to show no vasospasm and no difficulties of initiating sleep (screening with questionnaires and interview)

Exclusion Criteria:

  • bad health or unhealthy conditions
  • 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
Female
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00319371
074-GOB-2006-001, 02/06
No
Selim Orgül, MD, University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Study Director: Selim Orgül, MD University Eye Clinic Basel
University Hospital, Basel, Switzerland
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP