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Sleep Disturbances in Dermatology Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903263
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment
Sleep Disorder Diagnostic Test: survey on sleep disorders

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Study Type : Observational
Actual Enrollment : 624 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Sleep Disturbances in Dermatology Patients- a Survey
Actual Study Start Date : September 21, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

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


Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
outpatients of the dermatologic university clinic Basel
Criteria

Inclusion Criteria:

  • Outpatients of the dermatologic university clinic

Exclusion Criteria:

  • Insufficient knowledge of German language
  • Illiteracy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903263


Locations
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Switzerland
Department of Dermatology, University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Simon Müller, Dr. med Department of Dermatology, University Hospital Basel
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03903263    
Other Study ID Numbers: Req-2018-00772; sp19Mueller
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
dermatologic disease
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders