Pathophysiological Endotyping Using Baseline Polysomnography Data

NCT05267808 | Recruiting

• 1 other identifier: 2021 - 1777
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to develop models to predict site of collapse information using routine polysomnography. In an observational study, the investigators will study 1000 patients with obstructive sleep apnea (OSA) who have had a recent polysomnographic study and will undergo drug-induced sleep endoscopy (DISE) as part of their standard clinical care. Flow shape information from the polysomnographic study will be associated with the DISE results, and a set of prediction models will be developed and validated to detect the site, pattern and degree of upper airway collapse as seen during DISE.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; drug-induced sleep endoscopy; polysomnography

Outcome Measures

Primary Outcomes (1)

• The presence or absence of complete concentric collapse of the palate (CCCp) during drug-induced sleep endoscopy

  Results of drug-induced sleep endoscopy protocol. This protocol will be performed once in every patient. We will examine whether the odds of CCCP is greater in patients with predicted CCCP vs those with a predicted absence of CCCP.

  1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)

Secondary Outcomes (3)

• The presence or absence of complete tongue base collapse during drug-induced sleep endoscopy

  1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)

• The presence or absence of complete lateral wall collapse during drug-induced sleep endoscopy

  1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)

• The presence or absence of complete epiglottic collapse during drug-induced sleep

  1 procedure (outpatient clinic, up to 40 minutes of recording during drug-induced sleep)

Other Outcomes (6)

• Efficacy of oral appliance therapy: Change in apnea hypopnea index, %baseline

  >4 weeks per clinical protocol, average of 3 months

• Efficacy of hypoglossal nerve stimulation: Change in apnea hypopnea index, %baseline

  >4 weeks per clinical protocol, average of 3 months

• Efficacy of upper airway surgery: Change in apnea hypopnea index, %baseline

  >4 weeks per clinical protocol, average of 3 months

Study Arms (1)

Obstructive sleep apnea patients eligible for DISE

Patients with obstructive sleep apnea (AHI\>=5) will be included in the study. Subjects should be eligible for drug-induced sleep endoscopy as the next step in their clinical path.

Procedure: Drug-induced sleep endoscopy

Interventions

Drug-induced sleep endoscopy PROCEDURE

Endoscopy during drug-induced sleep

Obstructive sleep apnea patients eligible for DISE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed obstructive sleep apnea, who are eligible for drug-induced sleep endoscopy (DISE) as the next step in their clinical path.

You may qualify if:

• years or older.
• Diagnosis with OSA (AHI ≥ 5).
• Eligible for drug-induced sleep endoscopy as the next step in the clinical path for OSA.
• Capable of giving informed consent.

You may not qualify if:

• Diagnostic polysomnography data not available at the Antwerp University Hospital.
• Factors indicative of unstable clinical status or would preclude DISE investigation:
• Medication use related to sleeping disorders.
• Central Sleep Apnea Syndrome.
• Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy).
• Seizure disorders.
• Known medical history of intellectual disability, memory disorders or current psychiatric disorders (psychotic illness, major depression, or acute anxiety attacks as mentioned by the patient).
• Pregnancy or willing to become pregnant

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Olivier M Vanderveken, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Op de Beeck, PhD

CONTACT

0032 3 821 3385; sara.opdebeeck@uza.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 4, 2022
• Study Start: February 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

BE (1)