Typological Study of Sleep Pathologies During Psoriatic Rheumatism and SAPHO Syndrome: Prospective Study Within the Paris Saint-Joseph Hospital Group"
SleepSO2
2 other identifiers
observational
100
1 country
1
Brief Summary
Chronic inflammatory rheumatisms (CIR) are a source of motor disability and various comorbidities, particularly cardiovascular and metabolic. They also significantly impact patients' quality of life, including sleep disturbances. Among CIRs, psoriatic arthritis is a chronic inflammatory arthropathy associated with psoriasis, typically seronegative for rheumatoid factor. This heterogeneous disease affects peripheral and/or axial joints and can include extra-articular manifestations such as uveitis and chronic inflammatory bowel diseases. Its prevalence is estimated between 0.3% and 1% in the general population. SAPHO syndrome, similar to psoriatic arthritis, is characterized by specific bone involvement with a hypertrophic tendency, often affecting the axial skeleton and the anterior thoracic wall. Pain and inflammation are closely linked to sleep quality, creating a vicious cycle where pain disrupts sleep and poor sleep amplifies pain perception. Analgesic treatments, such as opioids, can also cause nocturnal respiratory pathologies, further disrupting sleep. Inflammatory processes are regulated by sleep, influencing plasma concentrations of CRP, IL6, and TNF production. Patients with psoriatic arthritis or SAPHO syndrome share common risk factors with Obstructive Sleep Apnea Syndrome (OSAS), such as obesity, hypertension, and metabolic syndrome. Sleep disorders are common in the general population and likely underdiagnosed in these patients. Several studies suggest a link between sleep disorders and these rheumatic conditions, affecting quality of life and exacerbating symptoms. Questionnaires like the Epworth and Pichot scales provide a more precise evaluation of these symptoms. However, objective sleep exploration through polysomnography has never been conducted in these patients. In summary, CIRs, particularly psoriatic arthritis and SAPHO syndrome, significantly impact patients' quality of life and sleep, necessitating appropriate evaluation and management of associated sleep disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 13, 2023
CompletedFirst Submitted
Initial submission to the registry
July 18, 2025
CompletedFirst Posted
Study publicly available on registry
July 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
July 25, 2025
July 1, 2025
3.5 years
July 18, 2025
July 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Type of sleep disorders
sleep disorders will be defined after polysomnography exam.
at 6months
Secondary Outcomes (8)
sleep structure
at 6 months
presence and severity of asthenia,
at enrollement
evaluation of anxiety
at enrollement
drowsiness evaluation
at enrollement
Evaluation of Sleep Apnea
at enrollement, at 6months and at 12 months
- +3 more secondary outcomes
Study Arms (3)
No sleep disorder
sleep apnea
other sleep disorder
Eligibility Criteria
patient diagnosed with psoriasis arthritis or SAPHO syndrome and presenting sleep disorder
You may qualify if:
- Patient aged 18 years or older
- Patient diagnosed with psoriatic arthritis or SAPHO syndrome and followed at Paris Saint-Joseph Hospital
- Patient presenting sleep disorders warranting hospitalization for further -investigation of these disorders
- French-speaking patient
- Patient who does not oppose participation in the research protocol
You may not qualify if:
- Patient already followed for a sleep disorder
- Patient who underwent polysomnography in the last 2 years
- End-of-life patient
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Paris Saint Joseph
Paris, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2025
First Posted
July 25, 2025
Study Start
November 13, 2023
Primary Completion (Estimated)
May 13, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
July 25, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share