OSAS (Obstructive Sleep Apneas Syndrome)NCT07459322
The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy
A study testing Remimazolam and Dexmedetomidine in people with OSAS (Obstructive Sleep Apneas Syndrome) and DISE, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial summary
This study seeks to compare the clinical efficacy and safety of the novel sedative Remimazolam with Dexmedetomidine in Drug-Induced Sleep Endoscopy (DISE), evaluating their performance in sedation depth stability, incidence of adverse events, and postoperative recovery time, thereby providing evidence-based guidance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSAS (Obstructive Sleep Apneas Syndrome), DISE, Sedation
- What is being tested?
- Remimazolam and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age > 18 years old
- American Society of Ansthesiologists functional class < III
- Schedule to receive DISE exam for evaluation of OSAS
Who cannot join
- Patient refusal
- Allergic to experimental medication
- History of central nervous system diseases
- History of psychiatric diseases
- Pregnancy
- Severe, uncontrolled systemic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Fu Jen Catholic University Hosptial
New Taipei City, Taiwan (r.o.c.), 24352
Chao-Hsien Sung, MD, 886905302091, joe411002@gmail.com
About this study
This study seeks to compare the clinical efficacy and safety of the novel sedative Remimazolam with Dexmedetomidine in Drug-Induced Sleep Endoscopy (DISE), evaluating their performance in sedation depth stability, incidence of adverse events, and postoperative recovery time, thereby providing evidence-based guidance for sedative selection in OSA patients. Additionally, it aims to develop a model for predicting upper airway obstruction sites by analyzing Polysomnography (PSG) data with artificial intelligence, enhancing diagnostic accuracy and treatment decision-making efficiency for Obstructive Sleep Apnea (OSA) to optimize clinical management.
- Conditions
- OSAS (Obstructive Sleep Apneas Syndrome), DISE, Sedation
- Being tested
- Remimazolam, Dexmedetomidine
- Keywords
- OSAS, DISE, Sedation, Remimazolam, Dexmedetomidine
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy
DexmedetomidineDrug
Patients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Patients with OSAS receiving dexmedetomidine for sedation during DISE | Active comparator | Patients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy Receives: Drug: Dexmedetomidine |
| Patients with OSAS receiving remimazolam for sedation during DISE | Experimental | Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apneic events
Apnea event during sedation
Measured: from start of sedation to outpatient discharge from postoperative care unit
Bradycardia
Heart rate less than 60 beats per minute during sedation
Measured: from start of sedation to outpatient discharge from postoperative care unit
Hypotension
Hypotensive event (defined as less mean blood pressure less than 80% of preoperative mean blood pressure) during sedation
Measured: from start of sedation to outpatient discharge from postoperative care unit
Agitation
Agitation, coughing, involuntary movement during sedation
Measured: from start of sedation to outpatient discharge from postoperative care unit
Surgeon satisfaction score
Rate of surgeon satisfaction of certain sedation
Measured: From start of sedation to outpatient discharge from postoperative care unit
Hypoxic event
hypoxic event during sedation
Measured: From start of sedation to outpatient discharge from postoperative care unit
Secondary outcomes (3)
Top-up requirement
Additional sedative agents given during sedation
Measured: From start of sedation to outpatient discharge from postoperative care unit
Patient satisfaction score
validated questionnaire regarding anesthesia quality in chinese after sedation for patients
Measured: Before outpatient discharge from postoperative care unit
VOTE classification prediction
Using electronic stethescope to collect snoring noise and predict VOTE classification
Measured: Perioperative phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start5 Aug 2026 (estimated)
- Primary completion5 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OSAS (Obstructive Sleep Apneas Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459322
- Sponsor's protocol ID
- FJUH114458
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cheong CS, Loke W, Thong MKT, Toh ST, Lee CH. The Emerging Role of Drug-Induced Sleep Endoscopy in the Management of Obstructive Sleep Apnea. Clin Exp Otorhinolaryngol. 2021 May;14(2):149-158. doi: 10.21053/ceo.2020.01704. Epub 2020 Oct 16.
PubMed 33092317Lucas-Borja ME, Zema DA, Fernandez C, Soria R, Miralles I, Santana VM, Perez-Romero J, Del Campo AD, Delgado-Baquerizo M. Limited contribution of post-fire eco-engineering techniques to support post-fire plant diversity. Sci Total Environ. 2022 Apr 1;815:152894. doi: 10.1016/j.scitotenv.2021.152894. Epub 2022 Jan 5.
PubMed 34998748Chen YT, Sun CK, Wu KY, Chang YJ, Chiang MH, Chen IW, Liao SW, Hung KC. The Use of Propofol versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy: A Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021 Apr 9;10(8):1585. doi: 10.3390/jcm10081585.
PubMed 33918644Yan L, Wang X, Chen Z, Wu N, Li H, Yang B. Safety and efficacy of remimazolam tosilate combined with low-dose fentanyl for procedural sedation in obese patients undergoing gastroscopy: study protocol for a single-centre, double-blind, randomised controlled trial. BMJ Open. 2023 Dec 28;13(12):e079095. doi: 10.1136/bmjopen-2023-079095.
PubMed 38154891Xin Y, Lu P, Guan S, Si S, Sun R, Xia W, Xu H. Efficacy and Safety of Remimazolam in Short Endoscopic Procedures: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2025 Mar 5;61(3):453. doi: 10.3390/medicina61030453.
PubMed 40142264
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy
- ClinicalTrials.gov ID
- NCT07459322
- Acronym / sponsor ID
- FJUH114458
- Conditions
- OSAS (Obstructive Sleep Apneas Syndrome), DISE, Sedation
- Keywords
- OSAS, DISE, Sedation, Remimazolam, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 5 Aug 2026 (estimated)
- Primary completion
- 5 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to compare the clinical efficacy and safety of the novel sedative Remimazolam with Dexmedetomidine in Drug-Induced Sleep Endoscopy (DISE), evaluating their performance in sedation depth stability, incidence of adverse events, and postoperative recovery time, thereby providing evidence-based guidance for sedative selection in OSA patients. Additionally, it aims to develop a model for predicting upper airway obstruction sites by analyzing Polysomnography (PSG) data with artificial intelligence, enhancing diagnostic accuracy and treatment decision-making efficiency for Obstructive Sleep Apnea (OSA) to optimize clinical management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with OSAS receiving dexmedetomidine for sedation during DISE | Active comparator | Drug: DexmedetomidinePatients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy |
| Patients with OSAS receiving remimazolam for sedation during DISE | Experimental | Drug: RemimazolamPatients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age > 18 years old
- American Society of Ansthesiologists functional class < III
- Schedule to receive DISE exam for evaluation of OSAS
Key exclusion criteria (6 listed)
- Patient refusal
- Allergic to experimental medication
- History of central nervous system diseases
- History of psychiatric diseases
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamPatients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy | Drug | Patients with OSAS receiving remimazolam for sedation during DISE |
| DexmedetomidinePatients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy | Drug | Patients with OSAS receiving dexmedetomidine for sedation during DISE |
Primary outcome
Apneic events
Time frame: from start of sedation to outpatient discharge from postoperative care unit
Apnea event during sedation
Bradycardia
Time frame: from start of sedation to outpatient discharge from postoperative care unit
Heart rate less than 60 beats per minute during sedation
Hypotension
Time frame: from start of sedation to outpatient discharge from postoperative care unit
Hypotensive event (defined as less mean blood pressure less than 80% of preoperative mean blood pressure) during sedation
Agitation
Time frame: from start of sedation to outpatient discharge from postoperative care unit
Agitation, coughing, involuntary movement during sedation
Surgeon satisfaction score
Time frame: From start of sedation to outpatient discharge from postoperative care unit
Rate of surgeon satisfaction of certain sedation
Hypoxic event
Time frame: From start of sedation to outpatient discharge from postoperative care unit
hypoxic event during sedation
3 secondary outcomes
Top-up requirement
Time frame: From start of sedation to outpatient discharge from postoperative care unit
Patient satisfaction score
Time frame: Before outpatient discharge from postoperative care unit
VOTE classification prediction
Time frame: Perioperative phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 33092317Cheong CS, Loke W, Thong MKT, Toh ST, Lee CH. The Emerging Role of Drug-Induced Sleep Endoscopy in the Management of Obstructive Sleep Apnea. Clin Exp Otorhinolaryngol. 2021 May;14(2):149-158. doi: 10.21053/ceo.2020.01704. Epub 2020 Oct 16.
- Background: PubMed 34998748Lucas-Borja ME, Zema DA, Fernandez C, Soria R, Miralles I, Santana VM, Perez-Romero J, Del Campo AD, Delgado-Baquerizo M. Limited contribution of post-fire eco-engineering techniques to support post-fire plant diversity. Sci Total Environ. 2022 Apr 1;815:152894. doi: 10.1016/j.scitotenv.2021.152894. Epub 2022 Jan 5.
- Background: PubMed 33918644Chen YT, Sun CK, Wu KY, Chang YJ, Chiang MH, Chen IW, Liao SW, Hung KC. The Use of Propofol versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy: A Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021 Apr 9;10(8):1585. doi: 10.3390/jcm10081585.
- Background: PubMed 38154891Yan L, Wang X, Chen Z, Wu N, Li H, Yang B. Safety and efficacy of remimazolam tosilate combined with low-dose fentanyl for procedural sedation in obese patients undergoing gastroscopy: study protocol for a single-centre, double-blind, randomised controlled trial. BMJ Open. 2023 Dec 28;13(12):e079095. doi: 10.1136/bmjopen-2023-079095.
- Background: PubMed 40142264Xin Y, Lu P, Guan S, Si S, Sun R, Xia W, Xu H. Efficacy and Safety of Remimazolam in Short Endoscopic Procedures: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2025 Mar 5;61(3):453. doi: 10.3390/medicina61030453.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam and Dexmedetomidine in people with OSAS (Obstructive Sleep Apneas Syndrome) and DISE, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Hsien Sung, MD (0905302091, joe411002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apneic events (time frame: from start of sedation to outpatient discharge from postoperative care unit). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07459322, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.