NCT07622745

Brief Summary

This study aimed to evaluate the effect of isolated nasal surgery on sleep-disordered breathing, particularly apnea-hypopnea index (AHI) and snoring index (SI), Apnea index (AI) and minimal arterial oxygen saturation (MAO2) in adults with obstructive sleep apnea syndrome (OSAS) and nasal obstruction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

2.3 years

First QC Date

May 23, 2026

Last Update Submit

June 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea Index

    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.

    3 months postoperatively

Secondary Outcomes (1)

  • Snoring index

    3 months postoperatively

Study Arms (3)

Group I

EXPERIMENTAL

Patients with nasal septal deviation and hypertrophied inferior turbinate (HIT) who underwent septoplasty with partial inferior turbinectomy.

Procedure: Septoplasty with partial inferior turbinectomy

Group II

EXPERIMENTAL

Patients with chronic rhinosinusitis with nasal polyps who underwent functional endoscopic sinus surgery (FESS) with nasal polypectomy.

Procedure: Nasal polypectomy

Group III

EXPERIMENTAL

Patients with isolated hypertrophied inferior turbinate (HIT) who underwent partial inferior turbinectomy alone.

Procedure: Partial inferior turbinectomy

Interventions

Patients with nasal septal deviation and hypertrophied inferior turbinate (HIT) who underwent septoplasty with partial inferior turbinectomy.

Group I

Patients with chronic rhinosinusitis with nasal polyps who underwent functional endoscopic sinus surgery (FESS) with nasal polypectomy.

Group II

Patients with isolated hypertrophied inferior turbinate (HIT) who underwent partial inferior turbinectomy alone.

Group III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Central or mixed sleep apnea.
  • Previous nasal surgery.
  • Unfitness for surgery.
  • Pathological obesity.
  • History of cardiopulmonary disease or asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Cairo, 11651, Egypt

Location

MeSH Terms

Conditions

SnoringSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Otorhinolaryngology, Faculty of Medicine, Al-Azhar University for Girls, Egypt.

Study Record Dates

First Submitted

May 23, 2026

First Posted

June 3, 2026

Study Start

March 1, 2022

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

June 3, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations