NCT06784479

Brief Summary

This study helps patients find the optimal sedation regimen in drug-induced sleep endoscopy

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

December 31, 2024

Last Update Submit

February 19, 2026

Conditions

Sedative Effect During Drug-induced Sleep EndoscopyObstructive Sleep Apnea (OSA)

Keywords

drug-induced sleep endoscopyremimazolampropofolObstructive sleep apneaairway collapsibility

Outcome Measures

Primary Outcomes (1)

  • sedation success rate

    a composite measure including completion of the DISE, no requirement for rescue sedative medication, and no requirement for more than 5 top-up doses of the trial medication after the initial dose.

    During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

Secondary Outcomes (7)

  • Procedure-related adverse effect-The need for antidote administration

    During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

  • Procedure-related adverse effect-The occurrence of tachycardia

    During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

  • Procedure-related adverse effect-The occurrence of hypotension

    During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

  • Procedure-related adverse effect-The occurrence of hypoxemia

    During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

  • The degree of patient and physician satisfaction

    During procedure (the start of drug induced sleep endoscopy to the complete awakening of the patient)

  • +2 more secondary outcomes

Study Arms (3)

Application of remimazolam and propofol to achieve satisfactory sedative effect

EXPERIMENTAL
Drug: Remimazolam and Propofol

Application of propofol to achieve satisfactory sedative effect

ACTIVE COMPARATOR
Drug: Propofol

Application of midazolam and propofol to achieve satisfactory sedative effect

ACTIVE COMPARATOR
Drug: Midazolam and propofol

Interventions

PropofolDRUG

Application of Propofol to induce sleep

Application of propofol to achieve satisfactory sedative effect
Remimazolam and PropofolDRUG

Application of Remimazolam and Propofol to induce sleep

Application of remimazolam and propofol to achieve satisfactory sedative effect
Midazolam and propofolDRUG

Application of Midazolam and Propofol to induce sleep

Application of midazolam and propofol to achieve satisfactory sedative effect

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with sleep apnea hypopnea syndrome were included

You may not qualify if:

  • Patients were excluded if they had nasal obstruction, significantly deviated nasal septum, nasal turbinate hypertrophy, or nasal polyps. Patients with uncontrolled heart failure, renal insufficiency, diabetes, or hyperthyroidism were also excluded. Patients were also excluded if taking medications that could affect upper airway muscle function, such as ben- zodiazepines and muscle relaxants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Endoscopy Center of Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

remimazolamPropofolMidazolam

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master of Medicine, attending physician

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 20, 2025

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

CN(1)