Diagnostic Method for Obstructive Sleep Apnea

(PREDICTOR Trial)

Recruiting at 9 trial locations

Overseen By Colin Huntley, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inspire Medical Systems, Inc.

Disqualifiers: Unable to lie supine, others

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: 1

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to diagnose obstructive sleep apnea, a condition where breathing stops and starts during sleep, for individuals considering airway surgery. Researchers aim to determine if a quick, simple mouth measurement can help decide if surgery is the right option. The study seeks participants diagnosed with obstructive sleep apnea who are already undergoing evaluation for surgery with a specific type of sleep test. As an unphased trial, it offers participants the chance to contribute to innovative research that could simplify the surgical decision-making process.

Do I have to stop taking my current medications for this trial?

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

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

Research has shown that airway surgery for obstructive sleep apnea (OSA) is generally safe. Studies have found that patients can undergo this surgery as an outpatient procedure without a significant increase in health risks. However, close monitoring after surgery is important, and some patients may need to stay overnight to ensure proper recovery.

One study found that airway surgery is a common treatment for OSA in adults, suggesting that doctors trust its safety. Overall, airway surgery is a well-tolerated option for people with OSA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new diagnostic method for identifying obstructive sleep apnea (OSA), which could significantly improve patient outcomes. Unlike current diagnostic approaches that often involve overnight sleep studies in a lab, this method could offer a less invasive and more accessible way to diagnose OSA. By potentially simplifying the diagnosis process, this method could make it easier for more patients to get timely and accurate diagnoses, leading to better management of their condition. Additionally, the trial might uncover insights into how airway surgery can be optimally integrated with diagnostic advances, paving the way for more personalized and effective treatment plans.

What evidence suggests that this diagnostic method is effective for obstructive sleep apnea?

Research has shown that surgery on the airways can help treat obstructive sleep apnea (OSA). Studies have found that operating on multiple parts of the upper airway can greatly improve sleep for patients who don't respond well to other treatments, such as CPAP (a machine that keeps airways open). One study found that combining surgeries on the palate and tongue helped patients with moderate to severe OSA. A review of several studies confirmed that surgery on multiple airway areas leads to significant improvements. These findings suggest that airway surgery can be a promising option for people with OSA. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for up to 300 people with obstructive sleep apnea who are being checked for airway surgery. They must meet the criteria for Inspire Upper Airway Stimulation and be undergoing a standard diagnostic procedure called drug-induced sleep endoscopy.

Inclusion Criteria

Patient meets the indications for the Inspire Upper Airway Stimulation

I am undergoing a sleep study to evaluate my sleep apnea before surgery.

Exclusion Criteria

Any other reason the investigator deems that the patient is unfit for participation in the study.

I cannot lie on my back for 2-3 minutes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Participants undergo standard evaluation for airway surgery, including a non-invasive measurement of pharyngeal width

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Airway Surgery

Trial Overview The study is exploring if a quick, non-invasive mouth measurement can predict airway collapse in patients with obstructive sleep apnea. This additional test takes just 2-3 minutes during their regular evaluation for airway surgery.

Airway Surgery is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Airway Surgery for:

• Obstructive Sleep Apnea

Approved in European Union as Upper Airway Surgery for:

• Obstructive Sleep Apnea
• Sleep-Related Breathing Disorders

Approved in Canada as Sleep Apnea Surgery for:

• Obstructive Sleep Apnea
• Snoring

Who Is Running the Clinical Trial?

Inspire Medical Systems, Inc.

Lead Sponsor

Trials

14

Recruited

6,800+

Published Research Related to This Trial

In a study of 1,547 patients who underwent ambulatory surgery, 44% were diagnosed with obstructive sleep apnea (OSA), but the rate of unplanned hospital admissions was not significantly higher in OSA patients (7.0%) compared to those without OSA (5.6%).

The severity of OSA did not correlate with an increased risk of unplanned admissions, suggesting that prior diagnosis of OSA may not necessitate additional postoperative monitoring for adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unplanned admission after day surgery: a historical cohort study in patients with obstructive sleep apnea. Bryson, GL., Gomez, CP., Jee, RM., et al.[2012]

The surgical procedure of tongue base reduction with hyoepiglottoplasty (TBRHE) showed an 80% success rate in treating severe obstructive sleep apnea syndrome (OSAS) in 10 male patients, significantly reducing their respiratory disturbance index (RDI) and improving symptoms like snoring and daytime sleepiness.

TBRHE was found to be a safe procedure with no neurovascular complications reported, making it a viable option for patients with tongue base obstruction who have not responded to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tongue base reduction with hyoepiglottoplasty: a treatment for severe obstructive sleep apnea. Chabolle, F., Wagner, I., Blumen, MB., et al.[2022]

The STOP questionnaire, consisting of four simple yes/no questions, was developed and validated as an effective screening tool for obstructive sleep apnea (OSA) in surgical patients, with a high sensitivity for identifying those at risk.

When combined with additional factors like body mass index, age, neck circumference, and gender, the STOP questionnaire achieved sensitivities of up to 100% for detecting moderate to severe OSA, making it a reliable preoperative assessment tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Chung, F., Yegneswaran, B., Liao, P., et al.[2022]

In a study of 306 surgical patients with obstructive sleep apnea syndrome, a two-phase surgical protocol achieved a success rate of 76.5% in improving airway obstruction, with a mean follow-up of 9.3 months.

Post-surgery, the respiratory disturbance index (RDI) improved significantly from a preoperative average of 55.8 to a postoperative average of 9.2, indicating effective reduction in sleep apnea severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea syndrome: a review of 306 consecutively treated surgical patients. Riley, RW., Powell, NB., Guilleminault, C.[2022]

In a study of 56 patients with severe obstructive sleep apnea (OSA), surgical airway reconstruction significantly improved key health metrics, with the mean respiratory disturbance index dropping from 58.7 to 10.0 and oxygen saturation increasing from 76.3% to 87.3%.

Patient satisfaction was high, with 95% of respondents reporting they were pleased with the results of the surgery and would choose to undergo the procedure again, indicating that the surgery is both effective and well-received from the patient's perspective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea surgery: patient perspective and polysomnographic results. Li, KK., Riley, RW., Powell, NB., et al.[2006]

The protocol aims to assist clinicians in accurately diagnosing sleep apnea syndrome, which is linked to different forms of upper airway obstruction.

This structured approach is designed to improve the management of patients suffering from sleep apnea, potentially leading to better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep apnea syndrome associated with upper airway obstruction. Sukerman, S., Healy, GB.[2015]

In a study of 452 adult obstructive sleep apnea patients undergoing head and neck airway surgery, 89% of the surgeries were performed on an outpatient basis, which is contrary to existing guidelines.

The study found a zero catastrophic complication rate among ambulatory patients, indicating that such surgeries can be performed safely, although pain-related emergency room visits were common.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of outpatient surgery for obstructive sleep apnea. Baugh, R., Burke, B., Fink, B., et al.[2013]

Surgical procedures like laser-assisted uvulopalatoplasty and radiofrequency ablation show limited efficacy in improving daytime sleepiness, quality of life, and reducing the apnea-hypopnea index or snoring, based on a systematic review of four studies.

About half of the patients experienced persistent side effects from uvulopalatopharyngoplasty and uvulopalatoplasty, with common issues including difficulty swallowing and voice changes, highlighting the need for caution and further research into safer surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and side-effects of surgery for snoring and obstructive sleep apnea--a systematic review. Franklin, KA., Anttila, H., Axelsson, S., et al.[2022]

Accurate diagnosis of obstruction sites in patients with obstructive sleep apnea is crucial and involves systematic examinations like nasopharyngoscopy and cephalometrics.

Surgical treatments for obstructive sleep apnea are tailored to the individual, ranging from less invasive procedures like septoplasty to more extensive surgeries such as maxillary and mandibular advancement in severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of obstructive sleep apnea syndrome (OSAS) Lydiatt, DD., Huerter, JV., Yonkers, AJ.[2004]

In a study of 35 patients with obstructive sleep apnea, a staged surgical reconstruction of the upper airway led to significant improvements, with 69% of patients achieving a postoperative respiratory disturbance index (RDI) of 20 or less, down from a mean preoperative RDI of 53.

The first stage of surgery, which included uvulopalatopharyngoplasty and mandibular osteotomy, was effective for most patients, and those who required further stages also showed positive outcomes, indicating that this approach can be beneficial for properly selected individuals with obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staged surgical treatment of obstructive sleep apnea syndrome: a review of 35 patients. Lee, NR., Givens, CD., Wilson, J., et al.[2019]

Polysomnography (PSG) is the standard method for diagnosing obstructive sleep apnea (OSA), but it does not determine the specific site of obstruction or predict surgical outcomes.

Various radiologic and diagnostic techniques, such as CT, MRI, and endoscopy, are being explored to improve the identification of obstruction sites and enhance the effectiveness of surgical interventions for OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic studies in obstructive sleep apnea. Thakkar, K., Yao, M.[2015]

A thorough airway evaluation, including a head and neck physical examination, is essential for surgical decision-making in patients with obstructive sleep apnea (OSA) to identify those at higher risk.

Endoscopy combined with cephalometrics is the preferred method for assessing airway obstruction, particularly for detecting multilevel obstructions, which can guide the intensity of surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting which patients will benefit from surgery for obstructive sleep apnea: the ENT exam. Woodson, BT.[2005]

Home sleep studies using portable systems can effectively evaluate patients with moderate to high suspicion of obstructive sleep apnea, showing good correlation with traditional lab-based polysomnography.

However, these home systems have limitations such as data collection issues and slightly reduced diagnostic accuracy, meaning that patients with unclear results should still undergo standard polysomnography for a definitive diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of portable sleep studies for diagnosis of obstructive sleep apnea. Boyer, S., Kapur, V.[2019]

The polysomnogram is the gold standard for diagnosing obstructive sleep apnea, providing objective data on sleep physiology, but it is expensive and time-consuming.

There is a need for alternative diagnostic technologies that could be more cost-effective and efficient while still accurately identifying obstructive breathing patterns during sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep studies. Current techniques and future trends. Coleman, J.[2019]

A review of 24 legal cases involving patients with known or suspected obstructive sleep apnea (OSA) undergoing surgery revealed that 71% of these patients experienced severe complications, including death and anoxic brain injury, highlighting the serious risks associated with OSA in the perioperative setting.

The study found that complications often occurred in unmonitored settings, with the use of opioids and general anesthetics implicated in many cases, leading to significant legal consequences, including an average financial penalty of $2.5 million for plaintiffs in successful malpractice suits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Complications in Obstructive Sleep Apnea Patients Undergoing Surgery: A Review of the Legal Literature. Fouladpour, N., Jesudoss, R., Bolden, N., et al.[2016]

Citations

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Redefining success in airway surgery for obstructive sleep ... In this review, we examine contemporary evidence that highlights the importance of highly effective treatment over sub-therapeutic treatment.

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Effectiveness of Treating Obstructive Sleep Apnea by ... Effectiveness of treating obstructive sleep apnea by surgeries and continuous positive airway pressure: evaluation using objective sleep parameters and patient ...

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Surgical outcomes in a retrospective cohort of adult ... We determined the effect of multilevel upper airway surgery on very severe OSA in continuous positive airway pressure (CPAP) non-adherent patients.

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2770361

Effect of Multilevel Upper Airway Surgery vs Medical ... In this preliminary study of adults with moderate or severe OSA who failed conventional treatment, combined palatal and tongue surgery improved patient- ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0385814621002479

Systematic review and updated meta-analysis of multi-level ... This study shows the significant improvement of treatment outcomes with multilevel surgery for OSA patients.

6. aao-hnsfjournals.onlinelibrary.wiley.com aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1002/ohn.691

Safety of Ambulatory Surgery For Obstructive Sleep Apnea: A ... Outpatient sleep surgery is generally safe. Close postoperative monitoring is necessary and overnight observation should be considered in those with very ...

7. link.springer.com link.springer.com/article/10.1007/s11325-024-03162-6

surgical failure in obstructive sleep apnea Upper airway (UA) surgery is commonly employed in the treatment of patients with obstructive sleep apnea (OSA).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2941427/

Surgical Modifications of the Upper Airway for Obstructive ... We conducted a systematic review and meta-analysis of literature reporting outcomes following various upper airway surgeries for the treatment of OSA in adults.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7491676/

Outcomes and safety among patients with obstructive sleep ... Patients with moderate, high-risk, or diagnosed OSA can safely undergo outpatient and advanced ambulatory oncology surgery without increased health care burden.