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

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03864809
• Other study ID #: SL disturb in psoriasis atopy
• Status: Not yet recruiting
• Start date: June 1, 2019
• Est. completion date: August 2020

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: manai mahmoud, Bachelor's
• Phone: 1025191410
• Email: amanimahmoud43[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Comparison between sleep disturbance in atopy and psoriasis and control

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2020
• Est. primary completion date: July 2020
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with Psoriasis and Patients with A topic dermatitis

Exclusion Criteria:

• All patient have another dermatological disease

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Psoriasis
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	.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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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