Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319371
Status:
COMPLETED
Last Update Posted:
2008-09-26
First Post:
2006-04-04
Brief Title:
Registration of Skin-Temperatures and Sleep-Wake Behaviour
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Registration of Skin-Temperatures and Sleep-Wake Behaviour in the Daily Life of Women With Vasospasm in Comparison to Controls
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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 ie 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
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 ie 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0206 | None | None | None |