DISE Phenotyping for Obstructive Sleep Apnea

(DISE-PhOP Trial)

Overseen By Erica Kent

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

241 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the understanding of obstructive sleep apnea, a condition that causes breathing problems during sleep. Researchers will use drug-induced sleep endoscopy (DISE) to examine how different factors affect airflow blockage in the throat. By applying nasal pressure and using imaging techniques, they aim to identify patterns that predict which surgical treatments will work best for individuals. Adults seeking alternatives to CPAP (a common sleep apnea treatment) and already scheduled for a DISE procedure might be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to better treatment options for sleep apnea.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for evaluating obstructive sleep apnea?

Research shows that drug-induced sleep endoscopy (DISE) is safe and easy to perform. Studies indicate that patients generally tolerate DISE well, with no reports of major side effects, suggesting it usually does not cause serious problems. This procedure helps doctors observe how the upper airway behaves during sleep-like conditions, aiding in the understanding and treatment of obstructive sleep apnea, a condition where breathing stops and starts during sleep. Overall, research supports the safety of DISE in people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Drug-induced sleep endoscopy (DISE) is unique because it offers a personalized way to pinpoint the exact areas in the throat where obstructions occur during sleep in patients with obstructive sleep apnea (OSA). Unlike traditional sleep studies or CPAP machines that provide a more generalized treatment, DISE happens while the patient is sedated, allowing doctors to directly observe and identify specific blockage points. Researchers are excited because this method could lead to more tailored and effective treatments, potentially improving outcomes and comfort for those suffering from OSA.

What evidence suggests that drug-induced sleep endoscopy could be effective for obstructive sleep apnea?

Research has shown that drug-induced sleep endoscopy (DISE), which participants in this trial will undergo, is a valuable tool for understanding obstructive sleep apnea (OSA). Studies have found that DISE helps identify patients who might benefit from surgeries like maxillomandibular advancement (MMA) by observing upper airway behavior in sleep-like conditions. One study found that surgeries guided by DISE were effective and safe for treating obstructive sleep apnea in children. Additionally, DISE reveals the extent of airway collapse, which is crucial for planning treatment. By using DISE, doctors can better predict which treatments might work best for each patient. ^{2 3 6 7 8}

Who Is on the Research Team?

Raj C Dedhia, MD, MSCR

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English and can consent to participate. It's specifically for those referred or scheduled for a DISE procedure, which examines the upper airway during sleep-like conditions, and are looking for alternatives to CPAP treatment for breathing issues during sleep.

Inclusion Criteria

I am referred for or scheduled to have a DISE procedure.

I speak English and can give informed consent.

I am looking for alternatives to CPAP for my sleep breathing issues.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Drug-Induced Sleep Endoscopy (DISE)

Participants undergo DISE to evaluate upper airway obstruction using CPAP, CT, and ultrasound

3 months

Multiple visits for DISE and imaging assessments

Follow-up

Participants are monitored for outcomes associated with surgical and non-surgical treatments

12 months

Regular follow-up visits to assess treatment outcomes

What Are the Treatments Tested in This Trial?

Interventions

• Drug-induced sleep endoscopy (DISE)
• Pharyngeal Manometry
• Submental Ultrasound

Trial Overview The study tests how well nasal pressure (CPAP) applied during DISE can identify functional causes of airflow blockage in sleep. It combines this with anatomic measurements from CT scans and submental ultrasound to predict success of standard surgical treatments.

How Is the Trial Designed?

Group I: Drug-Induced Sleep Endoscopy Experimental Treatment 2 Interventions

Drug-Induced Sleep Endoscopy

Drug-induced sleep endoscopy (DISE) is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as DISE for:

• Diagnosis and evaluation of obstructive sleep apnea

Approved in United States as DISE for:

• Diagnosis and evaluation of obstructive sleep apnea
• Pre-surgical evaluation for sleep apnea interventions

Approved in Canada as DISE for:

• Diagnosis and evaluation of obstructive sleep apnea

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Drug-induced sleep endoscopy (DISE) is a safe and effective method for evaluating obstructive sleep apnea (OSA) by identifying specific sites and patterns of airway obstruction, making it a valuable tool for treatment planning.

The study of 99 OSA patients found that common preoperative airway assessments, such as the Mallampati score and overall airway assessment, did not reliably predict patterns of airway collapse observed during DISE, reinforcing the importance of DISE as the gold standard for evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anesthesia airway evaluation: Correlation with sleep endoscopy findings. Eggerstedt, M., Urban, MJ., Chi, E., et al.[2020]

The propofol-remifentanil combination led to a significantly higher incidence of oxygen desaturation (77%) compared to the dexmedetomidine-remifentanil group (45%), indicating a safety concern with this regimen.

While the dexmedetomidine-remifentanil combination resulted in less respiratory depression, it was insufficient for adequate sedation in 50% of patients, suggesting that while it is safer, it may not be effective enough for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of three sedation regimens for drug-induced sleep endoscopy. Cho, JS., Soh, S., Kim, EJ., et al.[2021]

In a study of 61 adults with obstructive sleep apnea, elevating the head of the bed to 30° significantly reduced airway collapsibility during drug-induced sleep endoscopy, indicating a potential benefit for patients in managing their condition.

Despite the reduction in airway collapsibility with head elevation, there was no significant change in the VOTE scoring system, suggesting that while the airway may be less collapsible, the overall assessment of airway obstruction remains consistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of head of bed elevation on upper airway collapsibility during drug-induced sleep endoscopy. Owen, GS., Talati, VM., Zhang, Y., et al.[2023]

In a study of 19 patients with obstructive sleep apnea, drug-induced sleep endoscopy (DISE) revealed that those with low compliance to positive airway pressure (PAP) therapy had significantly higher TOTAL VOTE scores, indicating more severe pharyngeal obstruction when using PAP.

The study found that a TOTAL VOTE score of 2.5 or higher during DISE with PAP was associated with a 4.6-fold increased risk of low compliance, suggesting that DISE can effectively predict which patients may struggle with PAP therapy due to airway obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can drug-induced sleep endoscopy (DISE) predict compliance with positive airway pressure therapy? A pilot study. Yui, MS., Tominaga, Q., Lopes, BCP., et al.[2022]

Drug-induced sleep endoscopy (DISE) is becoming an important tool for assessing airway collapse in patients with sleep-disordered breathing, particularly for those not using CPAP therapies.

The study highlights a successful outpatient model where an ENT resident performs DISE with sedation managed by a nurse anesthetist, allowing for immediate discussion of findings and treatment recommendations on the same day, which could improve patient care efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organization and logistics of drug-induced sleep endoscopy in a training hospital. Benoist, LB., de Vries, N.[2018]

Drug-induced sleep endoscopy with positive airway pressure (DISE-PAP) is an innovative technique that enables doctors to visualize and assess the severity of upper airway collapse in patients.

This method is both cost-effective and efficient, making it easy to incorporate into clinical practice for better diagnosis and treatment of airway issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Implementation of Sleep Endoscopy with Positive Airway Pressure in Clinical Practice. Hutz, MJ., LoSavio, P.[2022]

Drug-induced sleep endoscopy (DISE) is a valuable diagnostic tool for evaluating the upper airway in patients with snoring and obstructive sleep apnea, simulating natural sleep conditions for more accurate assessments.

Standardization of the DISE procedure is crucial for obtaining reliable and reproducible results, which can enhance the interpretation of upper airway information and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-Induced Sleep Endoscopy: Technique, Indications, Tips and Pitfalls. Carrasco-Llatas, M., Matarredona-Quiles, S., De Vito, A., et al.[2020]

In a study of 87 patients undergoing surgery for obstructive sleep apnea (OSA), those who had drug-induced sleep endoscopy (DISE) showed a significantly lower rate of multilevel surgeries (8%) compared to those who did not undergo DISE (59.5%).

Patients who underwent preoperative DISE had a much higher surgical success rate of 86%, compared to only 51.4% in those without DISE, indicating that DISE helps tailor surgical plans effectively for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Drug Induced Sleep Endoscopy Improves the Surgical Approach to Treatment of Obstructive Sleep Apnea. Huntley, C., Chou, D., Doghramji, K., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12077109/

Comparative Analysis of Drug‐Induced Sleep Endoscopy ... This study investigates the correlation between CPAP therapeutic pressures from home AutoPAP data and PhOP during DISE‐PAP.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1389945722012643

Automatic scoring of drug-induced sleep endoscopy for ... This study demonstrates that automating scoring of DISE examinations show high validity and feasibility in degree of upper airway collapse.

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.9802

Evaluation of drug-induced sleep endoscopy as a tool for ... This study indicates that DISE is a promising tool to identify patients who will or will not respond to MMA for treating OSA.

4. e-ceo.org e-ceo.org/m/journal/view.php?doi=10.21053/ceo.2020.01704

The Emerging Role of Drug-Induced Sleep Endoscopy ... This review discusses the current knowledge and evidence on the role of drug-induced sleep endoscopy in the non-positive airway pressure management of ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33166755/

Outcome of drug induced sleep endoscopy directed ... Analysis of the results indicated that DISE directed surgery was an effective, safe therapeutic approach to treating paediatrics obstructive sleep apnoea.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6320559/

Drug Induced Sleep Endoscopy in Obstructive Sleep Apnea Our data suggest that DISE is safe and easy to perform, as previously reported. Furthermore, we found a good correlation between DISE findings and clinical ...

7. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A332/8135766

0767 A Role for Drug-Induced Sleep Endoscopy (DISE) in ... Drug-induced sleep endoscopy (DISE) is a dynamic tool used to evaluate airway collapse patterns in obstructive sleep apnea (OSA). When performed ...

8. iowaprotocols.medicine.uiowa.edu iowaprotocols.medicine.uiowa.edu/protocols/drug-induced-sleep-endoscopy-dise

Drug Induced Sleep Endoscopy (DISE) Obstructive sleep apnea (OSA) is characterized by a dynamic collapse of the upper aerodigestive tract during sleep. First line treatment is ...