- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07723417
DISE vs Muller's Maneuver in OSA Assessment
Role of Drug-Induced Sleep Endoscopy in Comparison to Muller's Maneuver in Obstructive Sleep Apnea Syndrome Assessment
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Obstructive sleep apnea (OSA) is one of the most common sleep-related breathing disorders and is characterized by recurrent episodes of partial or complete upper airway obstruction during sleep, leading to intermittent hypoxia, sleep fragmentation, and significant cardiovascular and metabolic consequences. Accurate localization of the site and pattern of upper airway collapse is essential for selecting the most appropriate treatment strategy.
Müller's maneuver is a commonly used office-based endoscopic technique that evaluates upper airway collapse during forced inspiratory effort while the patient is awake. However, its diagnostic accuracy has been questioned because it does not replicate the physiological conditions of natural sleep. Drug-Induced Sleep Endoscopy (DISE) is a dynamic endoscopic examination performed under sedation, allowing direct visualization of the upper airway during a sleep-like state and providing detailed information regarding the level, degree, and configuration of airway collapse.
The present prospective study aims to compare the findings of Drug-Induced Sleep Endoscopy with those obtained by Müller's maneuver in patients diagnosed with obstructive sleep apnea. The study will evaluate the agreement between both techniques in identifying the site and pattern of upper airway obstruction and assess the potential additional diagnostic value of DISE in the preoperative assessment and treatment planning of patients with OSA. The findings of this study may help optimize patient selection for individualized therapeutic interventions and improve clinical decision-making in the management of obstructive sleep apnea.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypt, 35511
- Mansoua University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Age > 18 years old.
- Diagnosed as OSAS according to polysomnography and AASM (June 2023).
- Body mass index < 40
Exclusion Criteria:
- Age < 18 years.
- Central sleep apnea.
- Hypoventilation syndromes.
- Cardiac arrhythmias.
- ischemic heart disease.
- Heart failure.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Single Study Arm
Participants with obstructive sleep apnea will undergo awake flexible endoscopy with Müller's maneuver followed by Drug-Induced Sleep Endoscopy (DISE).
The findings of both procedures will be compared to assess the site, degree, and pattern of upper airway obstruction.
|
Drug-induced sleep endoscopy performed under sedation to evaluate the site, degree, and pattern of upper airway collapse in patients with obstructive sleep apnea.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Agreement between Drug-Induced Sleep Endoscopy (DISE) using the VOTE cassification and Müller's Maneuver in assesment of OSA.
Tidsramme: Baseline (during the same study visit)
|
Agreement between Drug-Induced Sleep Endoscopy (DISE) findings, assessed using the VOTE classification, and Müller's maneuver findings in identifying the site, degree, and pattern of upper airway collapse in patients with obstructive sleep apnea.
Agreement will be quantified using Cohen's kappa coefficient.
|
Baseline (during the same study visit)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Lucy Soliman, Professor, Chest Medicine Department, Faculty of Medicine, Mansoura University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MS.24.12.3032
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .