Diagnostic Method for Obstructive Sleep Apnea

(PREDICTOR Trial)

Recruiting at 9 trial locations

Overseen By Phillip LoSavio, 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

Trial Summary

What is the purpose of this trial?

This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. Subjects will undergo standard evaluation for airway surgery as part of standard of care. In addition to the standard airway assessment, a simple, non-invasive measurement of the width of the inside of each subjects mouth will be performed. This measurement takes 2-3 minutes to perform.

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 data supports the idea that Diagnostic Method for Obstructive Sleep Apnea is an effective treatment?

The available research shows that surgical treatments for obstructive sleep apnea, such as airway surgery, have a success rate of 76.5% when compared to other methods like nasal continuous positive airway pressure (CPAP). This means that after surgery, many patients experienced improvements similar to those seen with CPAP, a common non-surgical treatment. The studies also highlight that patients had better breathing and oxygen levels during sleep after undergoing surgery. ^{1 2 3 4 5}

What safety data exists for surgery treating obstructive sleep apnea?

The safety of airway surgery for obstructive sleep apnea has been evaluated in several studies. One study focused on the safety of outpatient surgery for obstructive sleep apnea, while another systematically reviewed the efficacy and adverse effects of such surgeries. Additionally, perioperative complications, including severe neurologic injury and death, have been associated with obstructive sleep apnea in surgical patients. Guidelines suggest monitoring OSA patients postoperatively to reduce adverse events, as unplanned admissions after day surgery have been observed in OSA patients. ^{6 7 8 9 10}

Is Airway Surgery a promising treatment for Obstructive Sleep Apnea?

Airway Surgery is promising for treating Obstructive Sleep Apnea because it can be tailored to address specific areas of blockage in the airway. By accurately diagnosing where the obstruction occurs, doctors can perform surgery that targets those areas, potentially improving breathing during sleep. ^{11 12 13 14 15}

Eligibility Criteria

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

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

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

Timeline

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

Treatment Details

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Tongue base reduction with hyoepiglottoplasty: a treatment for severe obstructive sleep apnea. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Staged surgical treatment of obstructive sleep apnea syndrome: a review of 35 patients. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea syndrome: a review of 306 consecutively treated surgical patients. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea surgery: patient perspective and polysomnographic results. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Sleep apnea syndrome associated with upper airway obstruction. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Safety of outpatient surgery for obstructive sleep apnea. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Effects and side-effects of surgery for snoring and obstructive sleep apnea--a systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Perioperative Complications in Obstructive Sleep Apnea Patients Undergoing Surgery: A Review of the Legal Literature. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

STOP questionnaire: a tool to screen patients for obstructive sleep apnea. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Unplanned admission after day surgery: a historical cohort study in patients with obstructive sleep apnea. [2012]

11. United States pubmed.ncbi.nlm.nih.gov

Diagnostic studies in obstructive sleep apnea. [2015]

12. United States pubmed.ncbi.nlm.nih.gov

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

13. United States pubmed.ncbi.nlm.nih.gov

Role of portable sleep studies for diagnosis of obstructive sleep apnea. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment of obstructive sleep apnea syndrome (OSAS) [2004]

15. United States pubmed.ncbi.nlm.nih.gov

Sleep studies. Current techniques and future trends. [2019]