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

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ClinicalTrials.gov Identifier: NCT03864809
Recruitment Status : Not yet recruiting
First Posted : March 6, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Amani Mahmoud Abdelmohsen, Assiut University

Brief Summary:
Comparison between sleep disturbance in atopy and psoriasis and control

Condition or disease Intervention/treatment
Sleep Disturbance 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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: • Sleep Disturbance Among Patients With Psoriasis and Atopy and Comparison Between Them
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. severity of the psooriasis (Psoriasis Area and Severity Index) [ Time Frame: 1 hour ]

    calculation of the severity through questionaire , 0 = None

    1. = Slight
    2. = Moderate
    3. = Severe
    4. = Very severe


Secondary Outcome Measures :
  1. 2.HRQoL (Dermatology Life Quality Index); [ Time Frame: 1 hour ]
    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.

  2. .insomnia severity [Insomnia Severity Index (ISI)]; [ Time Frame: 1 hour ]

    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)


  3. sleep quality [Pittsburgh Sleep Quality Index (PSQI)]; [ Time Frame: 1 hour ]

    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


  4. stress (Perceived Stress Scale); [ Time Frame: 1 hour ]

    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


  5. itch (Itch Severity Scale); [ Time Frame: 1 hour ]
    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

  6. and depressive symptoms (Beck Depression Inventory [ Time Frame: 1 hour ]
    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

  7. severity of a topic dermatitis [ Time Frame: 1 hour ]
    The eczema area and severity index (EASI) Mild eczema score < 25 Moderate eczema score >25 <50 Severe eczema score >50



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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
Criteria

Inclusion Criteria:

- patients with Psoriasis and Patients with A topic dermatitis

Exclusion Criteria:

  • All patient have another dermatological disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864809


Contacts
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Contact: manai mahmoud, Bachelor's 1025191410 amanimahmoud43@gmail.com
Contact: saher abdelmoez, professor 01008899446 saharsotohy@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: radwa bakr, lecturer Assiut University

Publications:
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Responsible Party: Amani Mahmoud Abdelmohsen, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03864809     History of Changes
Other Study ID Numbers: SL disturb in psoriasis atopy
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psoriasis
Dyssomnias
Sleep Wake Disorders
Parasomnias
Skin Diseases, Papulosquamous
Skin Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms