Clinical trial NCT00319371: Registration of Skin-Temperatures and Sleep-Wake Behaviour
Official title: Registration of Skin-Temperatures and Sleep-Wake Behaviour in the Daily Life of Women With Vasospasm in Comparison to Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vasospastic Syndrome
Keywords: vasospasm
circadian
sleep-disorders
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2006-04-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Eye Clinic Basel
state: BS
Study officials:
affiliation: University Eye Clinic Basel
name: Selim Orgül, MD
role: STUDY_DIRECTOR
References: