Exploring the Patterns of Sleep Disordered Breathing in Systemic Sclerosis Patients

ConditionsSystemic Sclerosis Sleep-Disordered Breathing

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAssiut University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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 population

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

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Systemic sclerosis patients1 intervention

Trial outcomes

Primary outcomes

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

Time frame

6 hours

Sponsors and contacts

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Assiut University

Lead sponsor

Source ClinicalTrials.gov

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