NCT07086599

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Nov 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress63%
Nov 2023Nov 2027

Study Start

First participant enrolled

November 13, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

3.5 years

First QC Date

July 18, 2025

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Acquired Hyperostosis SyndromeSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Juliette COURTIADE MAHLER

CONTACT

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

Locations