Registration of Skin-Temperatures and Sleep-Wake Behaviour

University Hospital Basel

Status: Completed

Conditions: Vasospastic Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT00319371

074-GOB-2006-001

02/06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

1

Description:

women with vasospasm and difficulties of initiating sleep

2

Description:

women without vasospasm and no difficulties of initiating sleep