Systemic SclerosisNCT07175246
Exploring the Patterns of Sleep Disordered Breathing in Systemic Sclerosis Patients
An observational study of Systemic Sclerosis and Sleep-Disordered Breathing, run by Assiut University at 1 site in Egypt.
Trial summary
Systemic sclerosis (SSc) is a chronic autoimmune connective tissue disease characterized by progressive fibrosis of the skin and internal organs. Fatigue, non-restorative sleep, and poor sleep quality are frequently reported among patients with SSc, yet these symptoms remain under-recognized and under-investigated in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Sleep-Disordered Breathing
- What is being tested?
- Polysomnography (PSG)
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2025to 1 Oct 2026
- 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: Age ≥ 18 years, with Confirmed diagnosed of SSc (2013 ACR/EULAR criteria)
Who may be able to join
- Age ≥ 18 years, with Confirmed diagnosed of SSc (2013 ACR/EULAR criteria).
Who cannot join
- Pre-existing primary sleep disorders diagnosed before SSc diagnosis
- Use of sedatives or hypnotics within the last month that significantly alter sleep architecture
- Severe psychiatric or neurological conditions
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University hospital
Asyut, Asyut Governorate, 71515
Eman Ahmed Abd Elhamed, Resident, +21010363485, Eman.17289775@med.aun.edu.eg
Waleed Gamal Elddin, Ass. Prof., +21006519722, Waleedgamalddin@yahoo.com
About this study
Systemic sclerosis (SSc) is a chronic autoimmune connective tissue disease characterized by progressive fibrosis of the skin and internal organs. Fatigue, non-restorative sleep, and poor sleep quality are frequently reported among patients with SSc, yet these symptoms remain under-recognized and under-investigated in clinical practice. Despite growing awareness of the burden of sleep-related symptoms, there is a significant lack of objective data regarding sleep disturbances in this population, particularly those assessed using polysomnography (PSG).
Read the detailed description
Emerging evidence suggests a notable prevalence of sleep-disordered breathing (SDB), including obstructive sleep apnea (OSA), as well as periodic limb movement disorder (PLMD) and insomnia in individuals with SSc. The multi-factorial aetiology of sleep disturbances in SSc may involve fibrotic changes in the lungs, gastroesophageal reflux, musculoskeletal discomfort, and psychological stress. Moreover, pulmonary fibrosis and restrictive lung disease in SSc have been linked to an increased risk of nocturnal hypoxia and sleep fragmentation, which may worsen fatigue and impair quality of life.
Objective sleep assessment through PSG can provide essential insights into the type and severity of sleep disorders in SSc patients. Identifying these disorders early may guide more targeted management strategies, improve patients' daily functioning, and potentially alter disease outcomes. Hence, this study is warranted to fill the existing gap in knowledge and to explore the clinical implications of sleep disturbances in systemic sclerosis.
Study Objectives is to assess the occurrence and types of sleep disorders in systemic sclerosis patients, to evaluate polysomnographic findings in systemic sclerosis disease.
- Conditions
- Systemic Sclerosis, Sleep-Disordered Breathing
- Being tested
- Polysomnography (PSG)
- Keywords
- systemic sclerosis, Sleep Apnea, Insomnia
- Medical subject headings
- Scleroderma, Systemic, Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysomnography (PSG)Diagnostic test
Polysomnography (PSG) is the gold standard, multi-parametric diagnostic test used to comprehensively assess sleep architecture and diagnose sleep disorders. This objective, overnight recording captures simultaneous physiological data channels, including electroencephalography (EEG) to stage sleep, electrooculography (EOG) to detect eye movements, electromyography (EMG) to measure muscle tone, electrocardiography (ECG) for heart rhythm, respiratory effort (via thoracic and abdominal belts), nasal airflow, and pulse oximetry for blood oxygen saturation. As the primary/secondary outcome measure, PSG will be administered to quantitatively evaluate the intervention's effect on key sleep parameters such as total sleep time (TST), sleep efficiency (SE), wake after sleep onset (WASO), latency to sleep onset, and the frequency of sleep-disordered breathing events (e.g., Apnea-Hypopnea Index, AHI) or periodic limb movements.
| Study group | Role | What they receive |
|---|---|---|
| Systemic sclerosis patients | Adults (18 years and older) with a confirmed diagnosis of systemic sclerosis (2013 ACR/ EULAR criteria) Receives: Diagnostic Test: Polysomnography (PSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep disorders in systemic sclerosis patients
Apnea-Hypopnea Index (AHI)
Description: Average number of apneas and hypopneas per hour of sleep, assessed by overnight polysomnography.
Unit of Measure: Events per hour
Time Frame: 6 hours
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ahmed, Assiut University
- Investigators
- Eman Ahmed Abd Elhamed, Resident, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175246
- Sponsor's protocol ID
- Sleep-systemic-sclerosis
- Status last verified
- Jul 2025
- First submitted
- 21 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cholerzynska H, Zasada W, Tselios K, Grygiel-Gorniak B. Sleep Disorders in Connective Tissue Diseases-Coexisting Diseases or Disease Components? J Clin Med. 2024 Jun 22;13(13):3656. doi: 10.3390/jcm13133656.
PubMed 38999222Wongthawa N, So-Gnern A, Mahakkanukrauh A, Suwannaroj S, Foocharoen C. Sleep quality and clinical association with sleep disturbance in systemic sclerosis. BMC Rheumatol. 2023 Jul 21;7(1):21. doi: 10.1186/s41927-023-00346-7.
PubMed 37480089
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Patterns of Sleep Disordered Breathing in Systemic Sclerosis Patients
- ClinicalTrials.gov ID
- NCT07175246
- Acronym / sponsor ID
- Sleep-systemic-sclerosis
- Conditions
- Systemic Sclerosis, Sleep-Disordered Breathing
- Keywords
- systemic sclerosis, Sleep Apnea, Insomnia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 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.
Systemic sclerosis (SSc) is a chronic autoimmune connective tissue disease characterized by progressive fibrosis of the skin and internal organs. Fatigue, non-restorative sleep, and poor sleep quality are frequently reported among patients with SSc, yet these symptoms remain under-recognized and under-investigated in clinical practice. Despite growing awareness of the burden of sleep-related symptoms, there is a significant lack of objective data regarding sleep disturbances in this population, particularly those assessed using polysomnography (PSG).
Detailed description
Emerging evidence suggests a notable prevalence of sleep-disordered breathing (SDB), including obstructive sleep apnea (OSA), as well as periodic limb movement disorder (PLMD) and insomnia in individuals with SSc. The multi-factorial aetiology of sleep disturbances in SSc may involve fibrotic changes in the lungs, gastroesophageal reflux, musculoskeletal discomfort, and psychological stress. Moreover, pulmonary fibrosis and restrictive lung disease in SSc have been linked to an increased risk of nocturnal hypoxia and sleep fragmentation, which may worsen fatigue and impair quality of life.
Objective sleep assessment through PSG can provide essential insights into the type and severity of sleep disorders in SSc patients. Identifying these disorders early may guide more targeted management strategies, improve patients' daily functioning, and potentially alter disease outcomes. Hence, this study is warranted to fill the existing gap in knowledge and to explore the clinical implications of sleep disturbances in systemic sclerosis.
Study Objectives is to assess the occurrence and types of sleep disorders in systemic sclerosis patients, to evaluate polysomnographic findings in systemic sclerosis disease.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic sclerosis patients | – | Diagnostic Test: Polysomnography (PSG)Adults (18 years and older) with a confirmed diagnosis of systemic sclerosis (2013 ACR/ EULAR criteria) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age ≥ 18 years, with Confirmed diagnosed of SSc (2013 ACR/EULAR criteria)
Key inclusion criteria (1 listed)
- Age ≥ 18 years, with Confirmed diagnosed of SSc (2013 ACR/EULAR criteria).
Key exclusion criteria (4 listed)
- Pre-existing primary sleep disorders diagnosed before SSc diagnosis
- Use of sedatives or hypnotics within the last month that significantly alter sleep architecture
- Severe psychiatric or neurological conditions
- Refusal to participate in the study
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 |
|---|---|---|
| Polysomnography (PSG)Polysomnography (PSG) is the gold standard, multi-parametric diagnostic test used to comprehensively assess sleep architecture and diagnose sleep disorders. This objective, overnight recording captures simultaneous physiological data channels, including electroencephalography (EEG) to stage sleep, electrooculography (EOG) to detect eye movements, electromyography (EMG) to measure muscle tone, electrocardiography (ECG) for heart rhythm, respiratory effort (via thoracic and abdominal belts), nasal airflow, and pulse oximetry for blood oxygen saturation. As the primary/secondary outcome measure, PSG will be administered to quantitatively evaluate the intervention's effect on key sleep parameters such as total sleep time (TST), sleep efficiency (SE), wake after sleep onset (WASO), latency to sleep onset, and the frequency of sleep-disordered breathing events (e.g., Apnea-Hypopnea Index, AHI) or periodic limb movements. | Diagnostic test | Systemic sclerosis patients |
Primary outcome
sleep disorders in systemic sclerosis patients
Time frame: 6 hours
Apnea-Hypopnea Index (AHI) Description: Average number of apneas and hypopneas per hour of sleep, assessed by overnight polysomnography. Unit of Measure: Events per hour Time Frame: 6 hours
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 16 Sep 2025.
- Background: PubMed 38999222Cholerzynska H, Zasada W, Tselios K, Grygiel-Gorniak B. Sleep Disorders in Connective Tissue Diseases-Coexisting Diseases or Disease Components? J Clin Med. 2024 Jun 22;13(13):3656. doi: 10.3390/jcm13133656.
- Background: PubMed 37480089Wongthawa N, So-Gnern A, Mahakkanukrauh A, Suwannaroj S, Foocharoen C. Sleep quality and clinical association with sleep disturbance in systemic sclerosis. BMC Rheumatol. 2023 Jul 21;7(1):21. doi: 10.1186/s41927-023-00346-7.
- Individual participant dataSharing planned: No
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A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
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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.
Eman Ahmed Abd Elhamed, Resident principal investigator
Assiut University
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 Systemic Sclerosis and Sleep-Disordered Breathing, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 16 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 Egypt. 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 Eman Ahmed Abd Elhamed, Resident (+21010363485, Eman.17289775@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep disorders in systemic sclerosis patients (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07175246, which also lists 2 linked publications.
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 16 Sep 2025.