NCT03903263

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
624

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

April 2, 2019

Last Update Submit

April 10, 2019

Conditions

Sleep Disorder

Keywords

dermatologic disease

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

survey on sleep disordersDIAGNOSTIC_TEST

self-administered patient questionnaire regarding the different aspects of sleep disorders in patients with dermatologic diseases

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

outpatients of the dermatologic university clinic Basel

You may qualify if:

  • Outpatients of the dermatologic university clinic

You may not qualify if:

  • Insufficient knowledge of German language
  • Illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Sleep Wake DisordersSkin Diseases

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSkin and Connective Tissue Diseases

Study Officials

  • Simon Müller, Dr. med

    Department of Dermatology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 4, 2019

Study Start

September 21, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

April 11, 2019

Record last verified: 2019-04

Locations

CH(1)