Ultrasonographic of Diaphragmatic Function in Obstructive Sleep Apnea

NCT07370376 | Completed

• 1 other identifier: MS.23.03.2352
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is associated with altered respiratory mechanics, including diaphragmatic function. Ultrasonography provides a non-invasive tool to assess diaphragmatic structure and performance, which may correlate with OSA severity.

Conditions

OSA

Keywords

Ultrasonographic Assessment; Diaphragmatic Function; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Ultrasonographic Assessment of Diaphragmatic Function in Obstructive Sleep Apnea Patients

  All participants underwent diaphragm thickening fraction (DTF) as a percentage (%)

  6 months

Study Arms (2)

newly diagnosed OSA patients (AHI ≥5)

30 newly diagnosed OSA patients (AHI ≥5). All participants underwent pulmonary function testing, and completed Epworth Sleepiness Scale (ESS), Berlin, and STOP-Bang questionnaires. Overnight, attended polysomnography (PSG) was performed following AASM guidelines. Diaphragm ultrasonography measured excursion, thickness at end-expiration and inspiration, and diaphragm thickening fraction (DTF).

non-OSA controls (AHI <5)

All participants underwent pulmonary function testing, and completed Epworth Sleepiness Scale (ESS), Berlin, and STOP-Bang questionnaires. Overnight, attended polysomnography (PSG) was performed following AASM guidelines. Diaphragm ultrasonography measured excursion, thickness at end-expiration and inspiration, and diaphragm thickening fraction (DTF).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients visiting the Sleep Disordered Breathing (SDB) Unit at the Chest Medicine Department and diagnosed with obstructive sleep apnea (OSA) were included if they met the following criteria: Age 18-65 years.; OSA group: Newly diagnosed OSA confirmed by full-night polysomnography (PSG) with apnea-hypopnea index (AHI) \> 5 events/hour; Control group: Patients with AHI \< 5 events/hour on PSG; Willingness to participate in the study.

You may qualify if:

• Patients visiting the Sleep Disordered Breathing (SDB) Unit at the Chest Medicine Department and diagnosed with obstructive sleep apnea (OSA) were included if they met the following criteria:
• Age 18-65 years.
• Willingness to participate in the study.

You may not qualify if:

• Patients were excluded if they had any of the following conditions:
• Refusal to participate in the study
• Age \<18 or \>65 years
• Systemic organ failure, including heart failure, stroke, renal failure, or liver failure; Uncontrolled diabetes mellitus
• Diagnosed obesity hypoventilation syndrome (OHS) or other sleep disorders apart from OSA
• Chronic respiratory diseases such as COPD, bronchial asthma, or restrictive lung disease
• OSA patients already receiving therapy (CPAP, oral appliances, or upper airway surgery)
• Neuromuscular disorders or other conditions affecting diaphragmatic function (malnutrition, chest trauma, or immobility)
• Use of steroids or uncontrolled autoimmune diseases.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

30 newly diagnosed OSA patients (AHI ≥5) and 30 age- and sex-matched non-OSA controls (AHI \<5) were included. Exclusion criteria included systemic organ failure, uncontrolled diabetes, chronic respiratory diseases, neuromuscular disorders, prior OSA treatment, and steroid use. All participants underwent pulmonary function testing, and completed Epworth Sleepiness Scale (ESS), Berlin, and STOP-Bang questionnaires. Overnight, attended polysomnography (PSG) was performed following AASM guidelines. Diaphragm ultrasonography measured excursion, thickness at end-expiration and inspiration, and diaphragm thickening fraction (DTF).

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mohamed AbdElmoniem

  Lecturer of chest medicine faculty of medicine Mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of chest medicine

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 27, 2026
• Study Start: March 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2024
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

EG (1)