Sleep Disturbances in Dermatology Patients

Sleep Disorder Clinical Trial

Official title:

Sleep Disturbances in Dermatology Patients- a Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903263
• Other study ID #: Req-2018-00772; sp19Mueller
• Status: Completed
• Start date: September 21, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: April 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Outpatients of the dermatologic university clinic

Exclusion Criteria:

• Insufficient knowledge of German language

• Illiteracy

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• survey on sleep disorders
self-administered patient questionnaire regarding the different aspects of sleep disorders in patients with dermatologic diseases

Locations

Country	Name	City	State
Switzerland	Department of Dermatology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regensburg Insomnia Scale (RIS)	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).	single time point assessment at baseline