Psoriasis ArthritisSleepSO2NCT07086599
Typological Study of Sleep Pathologies During Psoriatic Rheumatism and SAPHO Syndrome: Prospective Study Within the Paris Saint-Joseph Hospital Group"
An observational study of Psoriasis Arthritis and SAPHO Syndrome, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Arthritis, SAPHO Syndrome, Sleep Apnea Syndromes
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2023to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: patient diagnosed with psoriasis arthritis or SAPHO syndrome and presenting sleep disorder
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Paris Saint Joseph
Paris
Juliette COURTIADE MAHLER, +33144127963, jcourtiade@ghpsj.fr
Quentin MARTEL, MD
About this study
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.
Read more
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.
- Conditions
- Psoriasis Arthritis, SAPHO Syndrome, Sleep Apnea Syndromes
- Medical subject headings
- Acquired Hyperostosis Syndrome, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No sleep disorder | Not described | |
| sleep apnea | Not described | |
| other sleep disorder | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of sleep disorders
sleep disorders will be defined after polysomnography exam.
Measured: at 6months
Secondary outcomes (8)
sleep structure
quantity of the different sleep stages as observed on the polysomnography exam
Measured: at 6 months
presence and severity of asthenia,
mesured by the PICHOT questionnar
Measured: at enrollement
evaluation of anxiety
mesured by HAD questionnaire
Measured: at enrollement
drowsiness evaluation
mesured with the Epworth Scale
Measured: at enrollement
Evaluation of Sleep Apnea
mesured with the STOP BANG questionnaire
Measured: at enrollement, at 6months and at 12 months
Sleep apnea severy
mesured by the Apnea/hypopnea index
Measured: at enrollemnt, 6months and 12 months after
Rheumatism disease activity
mesured with the DPASA score
Measured: at enrollement, after 6 months and after 12 months
CRP mesurement
expressed in mg/L
Measured: at enrollment, 6months and 12 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start13 Nov 2023
- Primary completion13 May 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis ArthritisStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086599
- Sponsor's protocol ID
- 642-SleepSO2
- Other IDs
- 2023-A01037-38
- Acronym
- SleepSO2
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Typological Study of Sleep Pathologies During Psoriatic Rheumatism and SAPHO Syndrome: Prospective Study Within the Paris Saint-Joseph Hospital Group"
- ClinicalTrials.gov ID
- NCT07086599
- Acronym / sponsor ID
- SleepSO2 / 642-SleepSO2
- Conditions
- Psoriasis Arthritis, SAPHO Syndrome, Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 13 May 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 25 Jul 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No sleep disorder | – | – |
| sleep apnea | – | – |
| other sleep disorder | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient diagnosed with psoriasis arthritis or SAPHO syndrome and presenting sleep disorder
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Type of sleep disorders
Time frame: at 6months
sleep disorders will be defined after polysomnography exam.
8 secondary outcomes
sleep structure
Time frame: at 6 months
presence and severity of asthenia,
Time frame: at enrollement
evaluation of anxiety
Time frame: at enrollement
drowsiness evaluation
Time frame: at enrollement
Evaluation of Sleep Apnea
Time frame: at enrollement, at 6months and at 12 months
Sleep apnea severy
Time frame: at enrollemnt, 6months and 12 months after
Rheumatism disease activity
Time frame: at enrollement, after 6 months and after 12 months
CRP mesurement
Time frame: at enrollment, 6months and 12 months after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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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.
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 Psoriasis Arthritis and SAPHO Syndrome, run by Fondation Hôpital Saint-Joseph 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliette COURTIADE MAHLER (+33144127963, jcourtiade@ghpsj.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of sleep disorders (time frame: at 6months). 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 25 Jul 2025.