Sleep Apnea, ObstructiveNCT07422402
Drug-Induced Sleep Endoscopy in Guiding Non-CPAP Therapy in Obstructive Sleep Apnea
A study testing Drug induced sleep endoscopy in people with Sleep Apnea, Obstructive, run by Mansoura University at 1 site in Egypt.
Trial summary
Continuous positive airway pressure (CPAP) remains the gold standard treatment for obstructive sleep apnea (OSA). However, many patients decline or fail CPAP therapy. Drug-induced sleep endoscopy (DISE) allows dynamic evaluation of upper airway collapse and may facilitate individualized non-CPAP treatment selection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Drug induced sleep endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥18 years
- OSA confirmed by attended PSG
- refusal of CPAP therapy.
Who cannot join
- Central sleep apnea
- severe systemic illness
- significant dental disease
- pregnancy
- craniofacial abnormalities
- temporomandibular joint disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Drug-Induced Sleep Endoscopy in Guiding Non-CPAP Therapy in Patients With Obstructive Sleep Apnea Syndrome
Continuous positive airway pressure (CPAP) remains the gold standard treatment for obstructive sleep apnea (OSA). However, many patients decline or fail CPAP therapy. Drug-induced sleep endoscopy (DISE) allows dynamic evaluation of upper airway collapse and may facilitate individualized non-CPAP treatment selection.
Read the detailed description
Continuous positive airway pressure (CPAP) remains the gold standard treatment for obstructive sleep apnea (OSA). However, many patients decline or fail CPAP therapy. Drug-induced sleep endoscopy (DISE) allows dynamic evaluation of upper airway collapse and may facilitate individualized non-CPAP treatment selection.
DISE-guided management provides significant clinical and polysomnographic improvement in CPAP-intolerant OSA patients. Individualized, anatomy-based therapy enhances treatment precision and outcomes.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Drug induced sleep endoscopy
- Keywords
- Obstructive Sleep Apnea, Drug induced sleep endoscopy
- 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.
Drug induced sleep endoscopyProcedure or surgery
evaluate the effectiveness of DISE-guided allocation between mandibular advancement device (MAD) therapy and upper airway surgery in OSA patients who refused CPAP.
| Study group | Role | What they receive |
|---|---|---|
| Drug-Induced Sleep Endoscopy in Obstructive Sleep Apnea | Experimental | evaluate the effectiveness of DISE-guided allocation between mandibular advancement device (MAD) therapy and upper airway surgery in OSA patients who refused CPAP. Receives: Procedure: Drug induced sleep endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in Apnea-Hypopnea Index (AHI) measured by polysomnography
evaluate the the change in Apnea-Hypopnea Index (AHI) measured by polysomnography from baseline to 3 months following DISE-guided allocation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jan 2025
- Primary completion1 Jul 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- evaluate the effectiveness of DISE-guided allocation between mandibular advancement device (MAD) therapy and upper airway surgery in OSA patients who refused CPAP.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MohamedAbdElmoniem, Mansoura University
- Investigators
- Mohamed AbdElmoniem, Principal investigator, Lecturer of chest medicine faculty of medicine Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422402
- Sponsor's protocol ID
- MD.24.05.854.R1
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Drug-Induced Sleep Endoscopy in Guiding Non-CPAP Therapy in Patients With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT07422402
- Acronym / sponsor ID
- MD.24.05.854.R1
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea, Drug induced sleep endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 20 Feb 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.
Continuous positive airway pressure (CPAP) remains the gold standard treatment for obstructive sleep apnea (OSA). However, many patients decline or fail CPAP therapy. Drug-induced sleep endoscopy (DISE) allows dynamic evaluation of upper airway collapse and may facilitate individualized non-CPAP treatment selection.
Detailed description
Continuous positive airway pressure (CPAP) remains the gold standard treatment for obstructive sleep apnea (OSA). However, many patients decline or fail CPAP therapy. Drug-induced sleep endoscopy (DISE) allows dynamic evaluation of upper airway collapse and may facilitate individualized non-CPAP treatment selection.
DISE-guided management provides significant clinical and polysomnographic improvement in CPAP-intolerant OSA patients. Individualized, anatomy-based therapy enhances treatment precision and outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- evaluate the effectiveness of DISE-guided allocation between mandibular advancement device (MAD) therapy and upper airway surgery in OSA patients who refused CPAP.
| Arm | Type | Receives |
|---|---|---|
| Drug-Induced Sleep Endoscopy in Obstructive Sleep Apnea | Experimental | Procedure: Drug induced sleep endoscopyevaluate the effectiveness of DISE-guided allocation between mandibular advancement device (MAD) therapy and upper airway surgery in OSA patients who refused CPAP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- OSA confirmed by attended PSG
- refusal of CPAP therapy.
Key exclusion criteria (6 listed)
- Central sleep apnea
- severe systemic illness
- significant dental disease
- pregnancy
- craniofacial abnormalities
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 |
|---|---|---|
| Drug induced sleep endoscopyevaluate the effectiveness of DISE-guided allocation between mandibular advancement device (MAD) therapy and upper airway surgery in OSA patients who refused CPAP. | Procedure or surgery | Drug-Induced Sleep Endoscopy in Obstructive Sleep Apnea |
Primary outcome
the change in Apnea-Hypopnea Index (AHI) measured by polysomnography
Time frame: 3 months
evaluate the the change in Apnea-Hypopnea Index (AHI) measured by polysomnography from baseline to 3 months following DISE-guided allocation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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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. This study is not recruiting at the moment.
Mohamed AbdElmoniem principal investigator
Lecturer of chest medicine faculty of medicine Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug induced sleep endoscopy in people with Sleep Apnea, Obstructive, run by Mansoura University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 20 Feb 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in Apnea-Hypopnea Index (AHI) measured by polysomnography (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2026.