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Completed

NCT Number: NCT00319371

Registration of Skin-Temperatures and Sleep-Wake Behaviour

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

University Eye Clinic Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Registration of Skin-Temperatures and Sleep-Wake Behaviour in the Daily Life of Women With Vasospasm in Comparison to Controls

Important dates

Study start
2005
Study completion
2006
First posted
Apr 27, 2006
Registry last updated
Sep 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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