Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07086599

Typological Study of Sleep Pathologies During Psoriatic Rheumatism and SAPHO Syndrome: Prospective Study Within the Paris Saint-Joseph Hospital Group"

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Paris Saint Joseph

Paris, France

Location status: Recruiting

Location contact

Juliette COURTIADE MAHLER

CONTACT

[email protected]

+33144127963

Quentin MARTEL, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Type of sleep disorders

    Time frame: at 6months

    sleep disorders will be defined after polysomnography exam.

Secondary outcomes

  1. sleep structure

    Time frame: at 6 months

    quantity of the different sleep stages as observed on the polysomnography exam

  2. presence and severity of asthenia,

    Time frame: at enrollement

    mesured by the PICHOT questionnar

  3. evaluation of anxiety

    Time frame: at enrollement

    mesured by HAD questionnaire

  4. drowsiness evaluation

    Time frame: at enrollement

    mesured with the Epworth Scale

  5. Evaluation of Sleep Apnea

    Time frame: at enrollement, at 6months and at 12 months

    mesured with the STOP BANG questionnaire

  6. Sleep apnea severy

    Time frame: at enrollemnt, 6months and 12 months after

    mesured by the Apnea/hypopnea index

  7. Rheumatism disease activity

    Time frame: at enrollement, after 6 months and after 12 months

    mesured with the DPASA score

  8. CRP mesurement

    Time frame: at enrollment, 6months and 12 months after

    expressed in mg/L

Study contacts

Contact information is provided by the study sponsor or research team.

Juliette COURTIADE MAHLER

CONTACT

[email protected]

+33144127963

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: SleepSO2

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.