Prevalence of Sleep Disturbances in Bullous Pemphigoid Patients.

NCT ID: NCT07188402

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-04
• Study Completion Date: 2024-01-01

Brief Summary

Bullous pemphigoid (BP) is the most common autoimmune blistering disorder. The incidence of BP has increased due to increased life expectancy, particularly in developed countries, which can be associated with multiple geriatric comorbidities and polypharmacy.

Epidemiological studies of BP have shown that the incidence ranges from 2.5 to 42.8 cases/million/year in European countries.

BP affects older adults with multiple comorbidities, primarily neurological diseases such as multiple sclerosis, dementia, Parkinson's disease, epilepsy, and stroke, which are usually diagnosed before BP.

Diagnosis is based on clinical suspicion combined with immunopathological investigations. The clinical chronological course is characterized by relapses and remissions. The goals of PB treatment are to stop the development of new skin lesions, healing of old lesions, and symptomatic therapy.

Detailed Description

The patient's physical and psychological state can be seriously affected by the disease itself or by the side effects of treatment. These effects could lead to a decrease in the patient's functional capacity and increase the burden, stress, and isolation of the patient and their family. These significant effects may be underestimated by healthcare professionals, which may be partly explained by the paucity of published reports on this particular problem.

Sleep is a fundamental, restorative, physiological, and neurobiological state that consumes approximately one-third of our lives. Sleep is carefully regulated by multiple processes, including homeostatic sleep and the circadian system. Itching and pain can significantly reduce patients' quality of life and sleep.

BP can be a stressful experience and places a significant burden on patients. Patients often have difficulty coping with new changes in daily tasks. Specific daily activities such as housekeeping, dressing, and showering can also be complicated. As a result, patients may experience frustration, depression, low self-esteem, and a reduced quality of life.

Furthermore, pain, itching, and discomfort can negatively impact sleep, mood, and enjoyment of life, further contributing to depression and frustration in these patients.

No studies have been published on the effect of bullous pemphigoid on sleep quality or the prevalence of sleep disturbances in bullous pemphigoid patients, except for a recent study published in January 2019 in the journal Clinical and Experimental Dermatology. This study was conducted in Poland and included a total of 31 participants. The researchers assessed sleep quality using a sleep monitor (Actisleep+) worn in the dominant hand. This study confirmed that PB patients have very poor sleep quality.

Using a patient-centered questionnaire (ISI questionnaire), this study aims to assess the prevalence of sleep disturbances and associated risk factors in patients with bullous pemphigoid. These data will be compared with those of age- and sex-matched control subjects. Control subjects will be recruited from dermatology department consultations and are being monitored for basal cell carcinoma, seborrheic keratosis, actinic keratosis, squamous cell carcinoma, or other benign skin tumors. These dermatological diseases are not known to affect sleep like psoriasis and atopic dermatitis. These control subjects therefore reflect the general population.

Conditions

Bullous Pemphigoid (BP)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

Prevalence of sleep disturbances in patients with bullous pemphigoid

Use of a questionnaire assessing the Insomnia Severity Index (ISI)

Intervention Type: OTHER

Prevalence of sleep disturbances in healthy volunteers without bullous pemphigoid

Use of a questionnaire assessing the Insomnia Severity Index (ISI)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adult Patient

2. Patients: Bullous Pemphigoid: Newly diagnosed by:

• Rash suggestive of Bullous Pemphigoid
• Histology: Subepidermal bulla or margination of eosinophils along the dermoepidermal junction (DEJ)
• Controls: Patient with Basal Cell Carcinoma, Squamous Cell Carcinoma, Seborrheic Keratosis, Actinic Keratosis, or Other Benign Skin Tumor. We selected the control group from these patients because these dermatological conditions do not affect sleep quality.

3. Mini Mental Status Examination (MMS) score > 20

4. No Formulated Opposition

Exclusion Criteria

1. Protected Adult

2. Advanced Dementia Syndrome

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Rouen Hospital

Rouen, , France

Countries

France

Other Identifiers

2020-A00837-32

Identifier Type: OTHER

Identifier Source: secondary_id

2020/088/OB

Identifier Type: -

Identifier Source: org_study_id