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Clinical Trials/NCT03903263
NCT03903263CompletedNot Applicable

Sleep Disturbances in Dermatology Patients- a Survey

University Hospital, Basel, Switzerland1 site in 1 country624 target enrollmentStarted: September 21, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
624
Locations
1
Primary Endpoint
Regensburg Insomnia Scale (RIS)

Study Overview

Brief Summary

This study is to investigate sleep disorders in patients with dermatologic diseases by taking into consideration dermatologic (itch, pain) and non- dermatologic (medication, depression) factors.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Outpatients of the dermatologic university clinic

Exclusion Criteria

  • Insufficient knowledge of German language
  • Illiteracy

Outcomes

Primary Outcomes

Regensburg Insomnia Scale (RIS)

Time Frame: single time point assessment at baseline

Self-rating scale: Five items cover quantitative and qualitative sleep parameters: Sleep latency (1), sleep duration (2), sleep continuity (3), early awakening (4) and sleep depth (5). Four items cover the psychological aspects of psychophysiological insomnia (PI), such as the experience of sleepless nights (6), focussing on sleep (7), fear of insomnia (8), and daytime fitness (9), one item covers sleep medication (10). A 5-step Likert scale was provided for response.The total score ranges from 0 to 40 points (score from 0-12 points considered as normal and a higher score as indicative of PI symptoms).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Basel, Switzerland
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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