- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07622745
Nasal Surgery in Snoring and Obstructive Sleep Apnea
Role of Nasal Surgery in Snoring and Obstructive Sleep Apnea
Study Overview
Status
Conditions
Detailed Description
Snoring is the noisy breathing that occurs throughout sleep, resulting from the vibration of the structures in the oral cavity, including the soft palate, uvula, tonsils, base of the tongue, epiglottis, as well as pharyngeal walls.
Obstructive sleep apnea syndrome (OSAS) is a respiratory sleep disorder distinguished by repeated episodes of partial or total occlusion of the upper airways throughout sleep. This blockage is typically associated with a decrease (hypopnea) or total cessation (apnea) of airflow in the upper airways, and sustained thoracic-diaphragmatic respiratory movements.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 11651
- Al-Azhar University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age above 18 years.
- Both sexes.
- Patients with anatomical nasal obstruction due to septal deviation, hypertrophied inferior turbinate (HIT), or nasal polyps refractory to medical treatment.
- Presence of snoring and obstructive sleep apnea (OSA).
- Fitness for surgery.
Exclusion Criteria:
- Central or mixed sleep apnea.
- Previous nasal surgery.
- Unfitness for surgery.
- Pathological obesity.
- History of cardiopulmonary disease or asthma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I
Patients with nasal septal deviation and hypertrophied inferior turbinate (HIT) who underwent septoplasty with partial inferior turbinectomy.
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Patients with nasal septal deviation and hypertrophied inferior turbinate (HIT) who underwent septoplasty with partial inferior turbinectomy.
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|
Experimental: Group II
Patients with chronic rhinosinusitis with nasal polyps who underwent functional endoscopic sinus surgery (FESS) with nasal polypectomy.
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Patients with chronic rhinosinusitis with nasal polyps who underwent functional endoscopic sinus surgery (FESS) with nasal polypectomy.
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Experimental: Group III
Patients with isolated hypertrophied inferior turbinate (HIT) who underwent partial inferior turbinectomy alone.
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Patients with isolated hypertrophied inferior turbinate (HIT) who underwent partial inferior turbinectomy alone.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Apnea-Hypopnea Index
Time Frame: 3 months postoperatively
|
The Apnea-Hypopnea Index (AHI) is a critical metric used to diagnose and rank the severity of sleep apnea.
It measures the average number of times your breathing completely stops (apneas) or becomes severely shallow (hypopneas) per hour of sleep.
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3 months postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Snoring index
Time Frame: 3 months postoperatively
|
The snoring index was defined as the number of snoring episodes divided by the hours of total sleep time
|
3 months postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Apnea
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Apnea Syndromes
- Respiratory Sounds
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Sleep Apnea, Obstructive
- Snoring
Other Study ID Numbers
- 1225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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