NCT03864809

Brief Summary

Comparison between sleep disturbance in atopy and psoriasis and control

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Status
unknown

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

First Submitted

Initial submission to the registry

February 26, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

February 26, 2019

Last Update Submit

March 5, 2019

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

  • severity of the psooriasis (Psoriasis Area and Severity Index)

    calculation of the severity through questionaire , 0 = None 1. = Slight 2. = Moderate 3. = Severe 4. = Very severe

    1 hour

Secondary Outcomes (7)

  • 2.HRQoL (Dermatology Life Quality Index);

    1 hour

  • .insomnia severity [Insomnia Severity Index (ISI)];

    1 hour

  • sleep quality [Pittsburgh Sleep Quality Index (PSQI)];

    1 hour

  • stress (Perceived Stress Scale);

    1 hour

  • itch (Itch Severity Scale);

    1 hour

  • +2 more secondary outcomes

Study Arms (3)

psoriasis patients

sleep disturbance

Behavioral: sleep disturbance

atopic dermatites patients

sleep disturbance

Behavioral: sleep disturbance

control

sleep disturbance

Behavioral: sleep disturbance

Interventions

sleep disturbanceBEHAVIORAL

we observe sleep disturbance among patients with psoriasis and atopic dermatitis and control group

atopic dermatites patientscontrolpsoriasis patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study involves the use of seven questionnaires to be given to subjects with psoriasis and a topic dermatites

You may qualify if:

  • \- patients with Psoriasis and Patients with A topic dermatitis

You may not qualify if:

  • All patient have another dermatological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jensen P, Zachariae C, Skov L, Zachariae R. Sleep disturbance in psoriasis: a case-controlled study. Br J Dermatol. 2018 Dec;179(6):1376-1384. doi: 10.1111/bjd.16702. Epub 2018 Aug 23.

    PMID: 29704428BACKGROUND

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • radwa bakr, lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

manai mahmoud, Bachelor's

CONTACT

1025191410amanimahmoud43@gmail.com

saher abdelmoez, professor

CONTACT

01008899446saharsotohy@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 6, 2019

Study Start

June 1, 2019

Primary Completion

July 1, 2020

Study Completion

August 1, 2020

Last Updated

March 7, 2019

Record last verified: 2019-03