• Sleep Disturbance Among Patients With Psoriasis and Atopy and Comparison Between Them

Comparison between sleep disturbance in atopy and psoriasis and control

Study Overview

• Status: Unknown
• Conditions: Sleep Disturbance
• Intervention / Treatment: Behavioral: sleep disturbance

Detailed Description

Sleep is essential for daytime functioning and health and important for both psychological and physiological wellbeing . A growing body of research indicates that chronic sleep disturbance is associated with impaired quality of life (QoL) and a risk factor for poorer health, for example depression cardiovascular disease, hypertension 1 and diabetes.

insomnia, the most common sleep disorder, is a clinical condition defined as difficulties falling asleep and/or maintaining sleep and/or poor sleep quality despite adequate opportunity for sleep resulting in significant daytime impairment.

The development of insomnia in healthy populations has a bi-directional relationship with psychological factors such as anxiety, depressive symptoms and stress, and may in clinical populations also be associated with physical symptoms, such as pain. the physical symptoms in psoriasis, such as itch, one would expect a higher prevalence of sleep disturbance in this patient group. On the other hand Sleep disturbance is common also in patients with atopic dermatitis (AD). Patients with AD often have sleep disturbances due to pruritus.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

- patients with Psoriasis and Patients with A topic dermatitis

Exclusion Criteria:

• All patient have another dermatological disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
psoriasis patients; sleep disturbance	Behavioral: sleep disturbance; we observe sleep disturbance among patients with psoriasis and atopic dermatitis and control group
atopic dermatites patients; sleep disturbance	Behavioral: sleep disturbance; we observe sleep disturbance among patients with psoriasis and atopic dermatitis and control group
control; sleep disturbance	Behavioral: sleep disturbance; we observe sleep disturbance among patients with psoriasis and atopic dermatitis and control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of the psooriasis (Psoriasis Area and Severity Index)	calculation of the severity through questionaire , 0 = None; = Slight; = Moderate; = Severe; = Very severe	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2.HRQoL (Dermatology Life Quality Index);	The aim of this questionnaire is to measure how much your skin problem has affected your life OVER THE LAST WEEK The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.	1 hour
.insomnia severity [Insomnia Severity Index (ISI)];	The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score. When you have your total score Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)	1 hour
sleep quality [Pittsburgh Sleep Quality Index (PSQI)];	The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. A total score of "5" or greater is indicative of poor sleep quality. If you scored "5" or more it is suggested that you discuss your sleep habits with a healthcare provider	1 hour
stress (Perceived Stress Scale);	The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often	1 hour
itch (Itch Severity Scale);	The ISS consists of seven questions that measure the severity of itch and the extent to which QoL is affected. The total score ranges from zero to 21	1 hour
and depressive symptoms (Beck Depression Inventory	This depression inventory can be self-scored 1-10____________________These ups and downs are considered normal 11-16___________________ Mild mood disturbance 17-20___________________Borderline clinical depression 21-30___________________Moderate depression 31-40___________________Severe depression over 40__________________Extreme depression	1 hour
severity of a topic dermatitis	The eczema area and severity index (EASI) Mild eczema score < 25 Moderate eczema score >25 <50 Severe eczema score >50	1 hour

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: radwa bakr, lecturer, Assiut University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Skin Diseases; Sleep Wake Disorders; Skin Diseases, Papulosquamous; Psoriasis; Dyssomnias; Parasomnias
• Other Study ID Numbers: SL disturb in psoriasis atopy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No