Obstructive Sleep ApneaDISE-PhOPNCT05050383
DISE: Phenotyping Obstruction Patterns
A study testing Pharyngeal Manometry in people with Obstructive Sleep Apnea, run by University of Pennsylvania at 1 site in United States.
Trial summary
Drug-induced sleep endoscopy (DISE) represents an opportunity to evaluate the upper airway in sleep-like conditions. In its current clinical form, however, DISE does not routinely determine the functional impact of anatomic and neuromuscular factors on airflow obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Pharyngeal Manometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2021to 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
- Adults (≥ 18yrs) willing and capable of providing informed consent
- Referred or scheduled for clinically indicated DISE procedure
- Seeking CPAP alternatives for treatment of sleep disordered breathing
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Drug-Induced Sleep Endoscopy (DISE): Phenotyping Obstruction Patterns
Drug-induced sleep endoscopy (DISE) represents an opportunity to evaluate the upper airway in sleep-like conditions. In its current clinical form, however, DISE does not routinely determine the functional impact of anatomic and neuromuscular factors on airflow obstruction.
The investigators will apply nasal pressure (CPAP) during DISE to generate pressure-flow relationships, deriving functional determinants of upper airway obstruction during sleep. In addition, they will use objective anatomic measurements from computerized tomography (CT) and submental ultrasound. The findings will allow the investigators to streamline the upper airway exam during DISE, and will further the goal of developing personalized solutions that address specific pathogenic mechanisms of pharyngeal collapse and airflow obstruction during sleep.
The investigators will use the physiologic and anatomic features derived from DISE and imaging to determine which are predictive of success to standard-of-care surgical interventions (e.g. skeletal, soft tissue, neurostimulation) .
Read the detailed description
Obstructive sleep apnea (OSA) is characterized by recurrent upper airway obstruction due to inadequate muscle tone during sleep leading to nocturnal hypercapnia, repeated oxyhemoglobin desaturations and arousals. Continuous positive airway pressure (CPAP) is the therapeutic mainstay for OSA, but adherence remains poor.
Currently, there exist 3 classes of surgical therapy for OSA, each addressing a specific pathologic structure: skeletal surgery (target: jaw bones), neurostimulation (target: tongue), and soft tissue (target: soft palate). Unfortunately, there is a critical knowledge gap in terms of accurately identifying a patient's underlying mechanism of obstruction; as a result, the efficacy of surgical treatment is limited.
Drug-induced sleep endoscopy (DISE) represents an opportunity to evaluate the upper airway in sleep-like conditions. In its current clinical form, however, DISE does not routinely determine the functional impact of anatomic and neuromuscular factors on airflow obstruction. In June 2020, the investigators implemented a pilot protocol (IRB # 833511) to utilize measures of airflow, pressure catheters, and ultrasound to enhance DISE exams. Over the course of 100 patients, they refined the research protocol to generate a safe, efficient, and comprehensive physiologic exam of the upper airway in the clinical setting (Dedhia et al, ORL, 2021, in press).
Upper airway pressure-flow relationships will be characterized during a standard-of-care DISE by stepping through a range of nasal pressure (CPAP) levels to derive functional determinants of upper airway obstruction during sleep. The investigators' preliminary work in this area has shown patients requiring lower pressures to restore airflow experience improved outcomes with neurostimulation surgery. Their overall hypothesis is that upper airway pressure-flow relationships can be used to predict response to all 3 major classes of sleep surgery: skeletal, neurostimulation, and soft tissue. They will address this hypothesis by characterizing upper airway pressure-flow relationships while utilizing objective anatomic measurements from CT and ultrasound. These findings will allow investigators to streamline the upper airway exam during DISE, and will further the goal of developing personalized solutions that address specific pathogenic mechanisms of pharyngeal collapse and airflow obstruction during sleep.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Pharyngeal Manometry
- Keywords
- sleep apnea, drug-induced sleep endoscopy, snoring
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal ManometryOther
Up to 3 catheters will be passed into the nose and advanced to the pharynx and/or the esophagus to measure airway pressures and/or breathing effort during drug-induced sleep.
| Study group | Role | What they receive |
|---|---|---|
| Drug-Induced Sleep Endoscopy | Other | Drug-Induced Sleep Endoscopy Receives: Other: Pharyngeal Manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the pathogenic determinants of airway obstruction at specific sites of pharyngeal collapse by characterizing upper airway pressure-flow relationships during DISE
Measured: Within 1 year of enrollment
Secondary outcomes (3)
Correlation of anatomic measurements from computerized tomography (CT) scans to physiologic findings from DISE
Craniofacial measurements of bones and soft tissues from CT scans
Measured: Within 3 months of enrollment
Compare positive airway pressure levels obtained from natural sleep to those during DISE
Therapeutic CPAP levels
Measured: Within 3 months of enrollment
Examine outcomes associated with non-surgical treatments (e.g. oral appliance therapy)
Polysomnography metrics (e.g., apnea:hypopnea ratio), questionnaire data (ESS, ISI, FOSQ-10, NOSE, Snoring VAS, etc.)
Measured: Within 1 year of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start12 Nov 2021
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 241 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raj Dedhia, MD, University of Pennsylvania
- Investigators
- Raj C Dedhia, MD, MSCR, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050383
- Sponsor's protocol ID
- 849542
- Acronym
- DISE-PhOP
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2021
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Induced Sleep Endoscopy (DISE): Phenotyping Obstruction Patterns
- ClinicalTrials.gov ID
- NCT05050383
- Acronym / sponsor ID
- DISE-PhOP / 849542
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep apnea, drug-induced sleep endoscopy, snoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 241 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Sep 2021 (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.
Drug-induced sleep endoscopy (DISE) represents an opportunity to evaluate the upper airway in sleep-like conditions. In its current clinical form, however, DISE does not routinely determine the functional impact of anatomic and neuromuscular factors on airflow obstruction.
The investigators will apply nasal pressure (CPAP) during DISE to generate pressure-flow relationships, deriving functional determinants of upper airway obstruction during sleep. In addition, they will use objective anatomic measurements from computerized tomography (CT) and submental ultrasound. The findings will allow the investigators to streamline the upper airway exam during DISE, and will further the goal of developing personalized solutions that address specific pathogenic mechanisms of pharyngeal collapse and airflow obstruction during sleep.
The investigators will use the physiologic and anatomic features derived from DISE and imaging to determine which are predictive of success to standard-of-care surgical interventions (e.g. skeletal, soft tissue, neurostimulation) .
Detailed description
Obstructive sleep apnea (OSA) is characterized by recurrent upper airway obstruction due to inadequate muscle tone during sleep leading to nocturnal hypercapnia, repeated oxyhemoglobin desaturations and arousals. Continuous positive airway pressure (CPAP) is the therapeutic mainstay for OSA, but adherence remains poor.
Currently, there exist 3 classes of surgical therapy for OSA, each addressing a specific pathologic structure: skeletal surgery (target: jaw bones), neurostimulation (target: tongue), and soft tissue (target: soft palate). Unfortunately, there is a critical knowledge gap in terms of accurately identifying a patient's underlying mechanism of obstruction; as a result, the efficacy of surgical treatment is limited.
Drug-induced sleep endoscopy (DISE) represents an opportunity to evaluate the upper airway in sleep-like conditions. In its current clinical form, however, DISE does not routinely determine the functional impact of anatomic and neuromuscular factors on airflow obstruction. In June 2020, the investigators implemented a pilot protocol (IRB # 833511) to utilize measures of airflow, pressure catheters, and ultrasound to enhance DISE exams. Over the course of 100 patients, they refined the research protocol to generate a safe, efficient, and comprehensive physiologic exam of the upper airway in the clinical setting (Dedhia et al, ORL, 2021, in press).
Upper airway pressure-flow relationships will be characterized during a standard-of-care DISE by stepping through a range of nasal pressure (CPAP) levels to derive functional determinants of upper airway obstruction during sleep. The investigators' preliminary work in this area has shown patients requiring lower pressures to restore airflow experience improved outcomes with neurostimulation surgery. Their overall hypothesis is that upper airway pressure-flow relationships can be used to predict response to all 3 major classes of sleep surgery: skeletal, neurostimulation, and soft tissue. They will address this hypothesis by characterizing upper airway pressure-flow relationships while utilizing objective anatomic measurements from CT and ultrasound. These findings will allow investigators to streamline the upper airway exam during DISE, and will further the goal of developing personalized solutions that address specific pathogenic mechanisms of pharyngeal collapse and airflow obstruction during sleep.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug-Induced Sleep Endoscopy | Other | Other: Pharyngeal ManometryDrug-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)
- Adults (≥ 18yrs) willing and capable of providing informed consent
- Referred or scheduled for clinically indicated DISE procedure
- Seeking CPAP alternatives for treatment of sleep disordered breathing
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Pharyngeal ManometryUp to 3 catheters will be passed into the nose and advanced to the pharynx and/or the esophagus to measure airway pressures and/or breathing effort during drug-induced sleep. | Other | Drug-Induced Sleep Endoscopy |
Primary outcome
To identify the pathogenic determinants of airway obstruction at specific sites of pharyngeal collapse by characterizing upper airway pressure-flow relationships during DISE
Time frame: Within 1 year of enrollment
3 secondary outcomes
Correlation of anatomic measurements from computerized tomography (CT) scans to physiologic findings from DISE
Time frame: Within 3 months of enrollment
Compare positive airway pressure levels obtained from natural sleep to those during DISE
Time frame: Within 3 months of enrollment
Examine outcomes associated with non-surgical treatments (e.g. oral appliance therapy)
Time frame: Within 1 year of enrollment
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 13 Oct 2026.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
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.
Raj C Dedhia, MD, MSCR principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharyngeal Manometry in people with Obstructive Sleep Apnea, run by University of Pennsylvania at 1 site in United States.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 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 United States. 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?
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?
To identify the pathogenic determinants of airway obstruction at specific sites of pharyngeal collapse by characterizing upper airway pressure-flow relationships during DISE (time frame: Within 1 year of enrollment). 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 13 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.