Exploring the Patterns of Sleep Disordered Breathing in Systemic Sclerosis Patients

NCT07175246 | Not Yet Recruiting DMC

• 1 other identifier: Sleep-systemic-sclerosis
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Systemic Sclerosis; Sleep-Disordered Breathing

Keywords

systemic sclerosis; Sleep Apnea; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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

  6 hours

Study Arms (1)

Systemic sclerosis patients

Adults (18 years and older) with a confirmed diagnosis of systemic sclerosis (2013 ACR/ EULAR criteria)

Diagnostic Test: Polysomnography (PSG)

Interventions

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.

Systemic sclerosis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age ≥ 18 years, with Confirmed diagnosed of SSc (2013 ACR/EULAR criteria)

You may qualify if:

• Age ≥ 18 years, with Confirmed diagnosed of SSc (2013 ACR/EULAR criteria).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (2)

• 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.

  PMID: 38999222 BACKGROUND

• Wongthawa 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.

  PMID: 37480089 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Systemic; Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Eman Ahmed Abd Elhamed, Resident

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Ahmed Abd Elhamed, Resident

CONTACT

+21010363485; Eman.17289775@med.aun.edu.eg

Waleed Gamal Elddin, ass. prof

CONTACT

+21006519722; waleedgamalddin@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 16, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)