NCT00319371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

First QC Date

April 4, 2006

Last Update Submit

September 25, 2008

Conditions

Vasospastic Syndrome

Keywords

vasospasmcircadiansleep-disorders

Study Arms (2)

1

women with vasospasm and difficulties of initiating sleep

2

women without vasospasm and no difficulties of initiating sleep

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women with vasospasm and difficulties of initiating sleep and women without vasospasm and no difficulties of initiating sleep

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Links

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Selim Orgül, MD

    University Eye Clinic Basel

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 27, 2006

Study Start

November 1, 2005

Study Completion

June 1, 2006

Last Updated

September 26, 2008

Record last verified: 2008-09

Locations

CH(1)