跳至主要内容
临床试验/CTRI/2025/10/095732
CTRI/2025/10/095732招募中不适用

Dimensional and volumetric analysis of the oropharyngeal region in Obstructive Sleep Apnea patients using Cone Beam Computed Tomography- a case control study

Dr Palak Jain Choudhary1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Comparison of oropharyngeal airway volume and Minimum cross sectional area between OSA patients and healthy controls

研究概览

简要总结

This observational study aims to evaluate volumetric and dimensional differences in the oropharyngeal airway between patients with Obstructive Sleep Apnea (OSA) and healthy individuals using upright Cone Beam Computed Tomography (CBCT) scans. Twenty subjects will be divided into two groups based on Epworth Sleepiness Scale (ESS), STOP-BANG scores, and Apnea-Hypopnea Index (AHI). Key parameters assessed include oropharyngeal airway volume, minimum cross-sectional area (MCA), anteroposterior and lateral dimensions, soft palate and tongue length. The study seeks to identify anatomical markers associated with OSA to support improved diagnostic and therapeutic strategies.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • group I-Obstructive Sleep Apnea patients- patients who will undergo Cone Beam Computed Tomography for various other diagnostic reasons (e.g., temporomandibular joint problems, condylar hyperplasia, assessment of impacted and supernumerary teeth etc).
  • patients with suspected symptoms of Obstructive Sleep Apnea diagnosed for it by following a standard protocol.
  • Epworth Sleepiness Scale more than 10, STOP BANG more than 3, Apnea Hypopnea Index more than 5 -Participants who provide written informed consent, agreeing to participate in the study and for their data to be used for research purposes.
  • Group II- non Obstructive Sleep Apnea patients -Individuals who will undergo Cone Beam Computed Tomography for various other diagnostic reasons (e.g., temporomandibular joint problems, condylar hyperplasia, assessment of impacted and supernumerary teeth, etc.).
  • Age and gender matched Participants -No history of snoring or any respiratory disorder -Epworth Sleepiness Scale score from 2 to 10 -A STOP-BANG questionnaire score of less than 3 -Having anatomically normal airway as seen on Cone Beam Computed Tomography scan with no radiologically evident pathology in the airway.
  • No history of cleft lip and palate, post maxillofacial trauma or surgery.

排除标准

  • •patients with heart disease •Pregnant women radiation hazards.
  • •History of craniofacial anomalies or surgeries •Neurological disorders affecting respiration •Incomplete Cone Beam Computed Tomography data •Individuals who have had major surgery or hospitalization within the last six months.
  • •Individuals who refuse to sign the consent agreement.

结局指标

主要结局

Comparison of oropharyngeal airway volume and Minimum cross sectional area between OSA patients and healthy controls

时间窗: at Baseline

次要结局

  • Differences in soft palate & tongue length(at Baseline)

研究者

发起方
Dr Palak Jain Choudhary
申办方类型
Other [nil]
责任方
Principal Investigator
主要研究者

Palak Jain Choudhary

Peoples College of Dental Sciences and Research Center

研究点 (1)

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