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
  Purpose

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.


Condition
Vasospastic Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Registration of Skin-Temperatures and Sleep-Wake Behaviour in the Daily Life of Women With Vasospasm in Comparison to Controls

Further study details as provided by University Hospital, Basel, Switzerland:

Enrollment: 40
Study Start Date: November 2005
Study Completion Date: June 2006
Groups/Cohorts
1
women with vasospasm and difficulties of initiating sleep
2
women without vasospasm and no difficulties of initiating sleep

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women with vasospasm and difficulties of initiating sleep and women without vasospasm and no difficulties of initiating sleep

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319371

Locations
Switzerland
University Eye Clinic Basel
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Director: Selim Orgül, MD University Eye Clinic Basel
  More Information

Additional Information:
No publications provided

Responsible Party: Selim Orgül, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00319371     History of Changes
Other Study ID Numbers: 074-GOB-2006-001, 02/06
Study First Received: April 4, 2006
Last Updated: September 25, 2008
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
vasospasm
circadian
sleep-disorders

ClinicalTrials.gov processed this record on October 22, 2014