- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07935057
Diaphragmatic Ultrasound and Hypoxic Burden in "Osa" (osa)
Diaphragmatic Ultrasound and Muscle Reserve in Obstructive Sleep Apnea Syndrome: Association With Nocturnal Hypoxic Burden and Polysomnographic Parameters
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Primary objective To investigate the association between diaphragmatic ultrasound-derived indices, particularly diaphragmatic reserve, and hypoxic burden in patients with OSA.
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Secondary objectives:
- To characterize diaphragmatic thickness, thickening fraction, and excursion in patients with OSA.
- To determine the relationship between diaphragmatic ultrasound parameters and polysomnographic parameters as: AHI, ODI, T90, mean SpO₂, minimum SpO₂, REM-AHI, supine AHI, arousal index.
Study Overview
Status
Conditions
Detailed Description
Obstructive sleep apnea (OSA) is a serious health condition that has been estimated to affect nearly 936 million adults aged between 30 and 69 worldwide according to recent to recent global estimates.
OSA is therefore a very common condition that results in several health consequences, such as cardiovascular pathology, metabolic disruptions, cognitive decline .
attended Polysomnography (PSG) is considered the gold standard for diagnosis of OSA ,with apnea-hypopnea index (AHI) as the more frequently used indicator of disease severity.
However in recent studies AHI have been shown to be inconsistently related to adverse consequences of OSA Hypoxic burden defined as the sum of individual area under oxygen saturation curves related to every respiratory event obtained by pulse oximeter during the total sleep time, has been suggested as a more accurate measure of OSA severity relating to symptoms and adverse effects.
The diaphragm as the most important muscle of respiration, can impact OSA severity although the extent of such effect is still unclear.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Abdulrahman Galal Salih, masters degree
- Phone Number: 00201111532712
- Email: abdogalal231295@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
adult patients who are confirmed to have OSA by polysomnography
Description
Inclusion Criteria:
- Aged > 18 years.
- Newly diagnosed OSA using PSG and meeting AASM diagnostic criteria.
- Treatment-naïve with respect to CPAP or other positive-airway-pressure therapy.
- Provide informed consent.
Exclusion Criteria:
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Respiratory diseases:
Bronchial asthma, COPD, bronchiectasis, interstitial lung disease, neuromuscular respiratory disease
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Neurological/diaphragmatic disorders:
Neuromuscular disorders, muscular dystrophies, previous major thoracic surgery affecting the diaphragm
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Other conditions:
decompensated heart failure, significant pulmonary hypertension, active malignancy acute respiratory infection
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_ONLY
- Time Perspectives: CROSS_SECTIONAL
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Establish a correlation between OSA severity and degree of diaphragmatic dysfunction using hypoxic burden related to diaphragmatic ultrasound parameters
Time Frame: Baseline
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Baseline
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the association between hypoxic burden and diaphragmatic thickness fraction after adjusted for AHI and BMI
Time Frame: Baseline
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Baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bordoni B, Escher AR, Toccafondi A, Mapelli L, Banfi P. Obstructive Sleep Apnea and Role of the Diaphragm. Cureus. 2022 Sep 10;14(9):e29004. doi: 10.7759/cureus.29004. eCollection 2022 Sep.
- Rundo JV. Obstructive sleep apnea basics. Cleve Clin J Med. 2019 Sep;86(9 Suppl 1):2-9. doi: 10.3949/ccjm.86.s1.02.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- diaphragmatic sonar in osa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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