Prevalence of Sleep Disturbances in Bullous Pemphigoid Patients.

NCT07188402 | Completed

• 2 other identifiers: 2020/088/OB2020-A00837-32
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Bullous Pemphigoid (BP)

Keywords

Sleep Disturbance Prevalence

Outcome Measures

Primary Outcomes (1)

• To examine the prevalence of sleep disturbances in patients with bullous pemphigoid compared to a control group using the Insomnia Severity Index (ISI) questionnaire annexed to this protocol.

  The Insomnia Severity Index (ISI), which is a brief instrument designed to assess the severity of both daytime and daytime components of insomnia. The total ISI score is interpreted as follows: * No insomnia (0-7) * Subthreshold insomnia (8-14) * Moderate insomnia (15-21) * Severe insomnia (22-28)

  Enrollment visit and month 1

Secondary Outcomes (1)

• Determination of disease-related predictors of sleep disorders

  Enrollment visit and month 1

Interventions

Prevalence of sleep disturbances in patients with bullous pemphigoid OTHER

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

Prevalence of sleep disturbances in healthy volunteers without bullous pemphigoid OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prospective, non-interventional, descriptive, multicenter case-control study based on a questionnaire (ISI questionnaire) aimed at patients with bullous pemphigoid and healthy volunteers, controls recruited during dermatology department consultations, followed for basal cell carcinoma, seborrheic keratosis, actinic keratosis, squamous cell carcinoma or other benign skin tumor known not to affect sleep.

You may qualify if:

• Adult Patient
• 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.
• Mini Mental Status Examination (MMS) score \> 20
• No Formulated Opposition

You may not qualify if:

• Protected Adult
• Advanced Dementia Syndrome

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Pemphigoid, Bullous

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 23, 2025
• Study Start: August 4, 2020
• Primary Completion: July 10, 2023
• Study Completion: January 1, 2024
• Last Updated: September 23, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)