Sleep DisorderNCT03903263
Sleep Disturbances in Dermatology Patients
An observational study of Sleep Disorder, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- survey on sleep disorders
- How many people
- 624 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Sep 2018to 31 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: outpatients of the dermatologic university clinic Basel
Who may be able to join
- Outpatients of the dermatologic university clinic
Who cannot join
- Insufficient knowledge of German language
- Illiteracy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Dermatology, University Hospital Basel
Basel, 4031
About this study
Official title: Sleep Disturbances in Dermatology Patients- a Survey
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.
- Conditions
- Sleep Disorder
- Being tested
- survey on sleep disorders
- Keywords
- dermatologic disease
- Medical subject headings
- Sleep Wake Disorders, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey on sleep disordersDiagnostic test
self-administered patient questionnaire regarding the different aspects of sleep disorders in patients with dermatologic diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: single time point assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start21 Sep 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Müller, Dr. med, Principal investigator, Department of Dermatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903263
- Sponsor's protocol ID
- Req-2018-00772; sp19Mueller
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbances in Dermatology Patients- a Survey
- ClinicalTrials.gov ID
- NCT03903263
- Acronym / sponsor ID
- Req-2018-00772; sp19Mueller
- Conditions
- Sleep Disorder
- Keywords
- dermatologic disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- outpatients of the dermatologic university clinic Basel
Key inclusion criteria (1 listed)
- Outpatients of the dermatologic university clinic
Key exclusion criteria (2 listed)
- Insufficient knowledge of German language
- Illiteracy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survey on sleep disordersself-administered patient questionnaire regarding the different aspects of sleep disorders in patients with dermatologic diseases | Diagnostic test | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
Related trials for Sleep Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Müller, Dr. med principal investigator
Department of Dermatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regensburg Insomnia Scale (RIS) (time frame: single time point assessment at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.