Precision OSA Therapy Based on Phenotypes and Endotypes

Sponsor
Nanjing Medical University
Study ID
NCT06825923
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Clinical and Endotypic Assessmen — OTHER
    This observational study involves a detailed clinical and endotypic assessment of patients diagnosed with Obstructive Sleep Apnea (OSA). Assessments include polysomnography (PSG) to measure sleep patterns and disturbances, drug-induced sleep endoscopy (DISE) to evaluate upper airway obstruction, and various biomarker analyses to characterize endotypic traits. The study aims to collect comprehensive phenotypic and endotypic data to develop predictive models for OSA patient characterization and management.

Study Details

Analyzing the phenotypic and endotypic characteristics of Sleep Apnea, along with DISE obstruction situations, is crucial for precise diagnosis and treatment. In this study, we aim to construct and apply a multidimensional predictive model based on four aspects: basic physiological characteristics of OSA, clinical phenotypes, mechanistic endotypes, and DISE obstruction levels. The study will begin by categorizing the clinical phenotypes; subsequently, it will quantify endotypic indicators based on PSG signal information and construct the PALM scale for Chinese individuals. Following this, a comprehensive clinical profile and a treatment efficacy prediction model for OSA patients will be built based on the results from the aforementioned multidimensional data.

Key Dates

First listed
Feb 13, 2025
Start date
Jul 1, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: OSA Comprehensive Assessment Group
    This group comprises patients diagnosed with Obstructive Sleep Apnea (OSA). Participants will undergo a comprehensive assessment that includes baseline demographic data collection, clinical symptom evaluation, polysomnography (PSG), Drug-Induced Sleep Endoscopy (DISE), and various physiological measurements to identify specific phenotypic and endotypic traits associated with OSA. This holistic evaluation aims to facilitate detailed phenotyping and generate predictive models for personalized treatment approaches.

Primary Outcome Measure

Phenotype and Endotype Classification [ Time Frame: 12 months post-enrollment. ]

Central Contacts

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