Bullous Pemphigoid (BP)SLEEP-BPNCT07188402
Prevalence of Sleep Disturbances in Bullous Pemphigoid Patients.
An observational study of Bullous Pemphigoid (BP), run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bullous Pemphigoid (BP)
- What is being tested?
- Prevalence of sleep disturbances in patients with bullous pemphigoid and Prevalence of sleep disturbances in healthy volunteers without bullous pemphigoid
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 4 Aug 2020to 1 Jan 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Protected Adult
- Advanced Dementia Syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Disturbance Prevalence In Bullous Pemphigoid Patients
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.
Read more
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.
Read the 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)
- Being tested
- Prevalence of sleep disturbances in patients with bullous pemphigoid, Prevalence of sleep disturbances in healthy volunteers without bullous pemphigoid
- Keywords
- Sleep Disturbance Prevalence
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevalence of sleep disturbances in patients with bullous pemphigoidOther
Use of a questionnaire assessing the Insomnia Severity Index (ISI)
Prevalence of sleep disturbances in healthy volunteers without bullous pemphigoidOther
Use of a questionnaire assessing the Insomnia Severity Index (ISI)
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Enrollment visit and month 1
Secondary outcomes (1)
Determination of disease-related predictors of sleep disorders
To examine potential disease-related predictors of sleep disorders using the Pemphigus Disease Area Index (BPDAI) score. The Pemphigus Disease Area Index (PDAI) is a standardized clinical tool used to assess the severity and extent of lesions in patients with pemphigus, a rare autoimmune disease that causes bullae (blisters) on the skin and mucous membranes. Score O = Complete remission; Score 1 to 15 mild illness; Score 16 to 45 Moderate disease; score > 46 severe illness.
Measured: Enrollment visit and month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start4 Aug 2020
- Primary completion10 Jul 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous Pemphigoid (BP)Studies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188402
- Sponsor's protocol ID
- 2020/088/OB
- Other IDs
- 2020-A00837-32
- Acronym
- SLEEP-BP
- Status last verified
- Mar 2025
- First submitted
- 17 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbance Prevalence In Bullous Pemphigoid Patients
- ClinicalTrials.gov ID
- NCT07188402
- Acronym / sponsor ID
- SLEEP-BP / 2020/088/OB
- Conditions
- Bullous Pemphigoid (BP)
- Keywords
- Sleep Disturbance Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Adult Patient
- Patients: Bullous Pemphigoid: Newly diagnosed by:
- Mini Mental Status Examination (MMS) score > 20
- No Formulated Opposition
Key exclusion criteria (2 listed)
- Protected Adult
- Advanced Dementia Syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevalence of sleep disturbances in patients with bullous pemphigoidUse of a questionnaire assessing the Insomnia Severity Index (ISI) | Other | – |
| Prevalence of sleep disturbances in healthy volunteers without bullous pemphigoidUse of a questionnaire assessing the Insomnia Severity Index (ISI) | Other | – |
Primary outcome
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.
Time frame: Enrollment visit and month 1
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)
1 secondary outcome
Determination of disease-related predictors of sleep disorders
Time frame: Enrollment visit and month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
Related trials for Bullous Pemphigoid (BP)
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Enrolling by invitationPhase 1
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Active, not recruitingObservational study
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Not yet recruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bullous Pemphigoid (BP), run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Enrollment visit and month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.