Registration of Skin-Temperatures and Sleep-Wake Behaviour

Vasospastic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319371
• Other study ID #: 074-GOB-2006-001
• Secondary ID: 02/06
• Status: Completed
• Phase: N/A
• First received: April 4, 2006
• Last updated: September 25, 2008
• Start date: November 2005
• Est. completion date: June 2006

Study information

• Verified date: September 2008
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vasospastic Syndrome

Locations

Country	Name	City	State
Switzerland	University Eye Clinic Basel	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

External Links

•   Link
•   Link