Diagnostic Method for Obstructive Sleep Apnea
(PREDICTOR Trial)
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Inspire Medical Systems, Inc.
No Placebo Group
Approved in 3 Jurisdictions
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.12345
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.678910
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.1112131415
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.
Treatment Details
Interventions
- Airway Surgery (Procedure)
Trial OverviewThe 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Pittsburgh Medical CenterPittsburgh, PA
Vanderbilt University Medical CenterNashville, TN
Valley ENTScottsdale, AZ
Rush University Medical CenterChicago, IL
More Trial Locations
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Who Is Running the Clinical Trial?
Inspire Medical Systems, Inc.Lead Sponsor
References
Tongue base reduction with hyoepiglottoplasty: a treatment for severe obstructive sleep apnea. [2022]To describe a surgical procedure for the treatment of severe obstructive sleep apnea syndrome (OSAS), the procedure's indications, and its results.
Staged surgical treatment of obstructive sleep apnea syndrome: a review of 35 patients. [2019]The purpose of this study was to investigate the success of a staged surgical reconstruction of the upper airway for treatment of obstructive sleep apnea syndrome.
Obstructive sleep apnea syndrome: a review of 306 consecutively treated surgical patients. [2022]Three hundred six consecutively treated surgical patients with obstructive sleep apnea syndrome were evaluated from a group of 415 patients. One hundred nine patients were excluded because they failed to obtain a postoperative polysomnogram or were lost to followup. All patients received a physical examination, cephalometric analysis, fiberoptic examination, and polysomnography before treatment to document OSAS and determine the areas of obstruction. A two-phase surgical protocol was used for the reconstruction of the upper airway. Phase I surgery consisted of a uvulopalatopharyngoplasty (UPPP) for palatal obstruction and genioglossus advancement with hyoid myotomy-suspension for base of tongue obstruction. Failures of phase I were offered phase 2 reconstruction, which consisted of maxillary-mandibular advancement osteotomy. One hundred twenty-one patients were treated with nasal continuous positive airway pressure (CPAP) before surgery and this was the primary method of evaluating surgical success. Results were reported on the polysomnogram performed a minimum of 6 months after surgery and compared to the preoperative polysomnogram and the second night nasal CPAP study. The polysomnographic results included respiratory disturbance index (RDI), lowest oxyhemoglobin saturation (LSAT), and sleep architecture parameters. Surgery was considered a success if it was equivalent to nasal CPAP or the postoperative RDI was less than 20 with normal oxygenation. The overall success rate, which included patients that dropped from the protocol, was 76.5%, with a mean followup of 9.3 months (SD, 6.7). The preoperative RDI, nasal CPAP RDI, and postoperative RDI were 55.8 (SD, 26.7), 7.2 (SD, 5.4), and 9.2 (SD, 7.5), respectively.(ABSTRACT TRUNCATED AT 250 WORDS)
Obstructive sleep apnea surgery: patient perspective and polysomnographic results. [2006]The goal of this study was to assess the outcomes of obstructive sleep apnea (OSA) surgery based on the patient perspective and polysomnographic data.
Sleep apnea syndrome associated with upper airway obstruction. [2015]A working protocol is presented which has developed to help the clinician in the diagnosis and management of patients suffering from the sleep apnea syndrome associated with various types of upper airway obstruction.
Safety of outpatient surgery for obstructive sleep apnea. [2013]Determine the safety experience of adult obstructive sleep apnea patients undergoing airway surgery.
Effects and side-effects of surgery for snoring and obstructive sleep apnea--a systematic review. [2022]Many patients undergo surgery for snoring and sleep apnea, although the efficacy and safety of such procedures have not been clearly established. Our aim was systematically to review studies of the efficacy and adverse effects of surgery for snoring and obstructive sleep apnea.
Perioperative Complications in Obstructive Sleep Apnea Patients Undergoing Surgery: A Review of the Legal Literature. [2016]Obstructive sleep apnea (OSA) is common in patients undergoing surgery. OSA, known or suspected, has been associated with significant perioperative adverse events, including severe neurologic injury and death. This study was undertaken to assess the legal consequences associated with poor outcomes related to OSA in the perioperative setting.
STOP questionnaire: a tool to screen patients for obstructive sleep apnea. [2022]Obstructive sleep apnea (OSA) is a major risk factor for perioperative adverse events. However, no screening tool for OSA has been validated in surgical patients. This study was conducted to develop and validate a concise and easy-to-use questionnaire for OSA screening in surgical patients.
Unplanned admission after day surgery: a historical cohort study in patients with obstructive sleep apnea. [2012]Practice guidelines suggest that patients with obstructive sleep apnea (OSA) should be monitored postoperatively to reduce adverse events. This study evaluated outcomes following ambulatory surgery in patients who had previously undergone polysomnography (PSG), and compared unplanned admissions in patients diagnosed with OSA with those in patients without OSA.
Diagnostic studies in obstructive sleep apnea. [2015]The standard for the diagnosis of obstructive sleep apnea (OSA) is polysomnography (PSG). Although PSG helps identify individuals who have OSA and guides medical management, it does not identify the obstruction site or predict surgical results. Radiologic and diagnostic studies have been used to direct surgical intervention and predict outcomes of sleep apnea surgery. These studies include lateral cephalometric radiographs, CT, MRI, asleep fluoroscopy, asleep and awake endoscopy, upper airway manometry, and acoustic reflection techniques. The ideal diagnostic study would identify individuals who have OSA, be cost-effective and readily accessible, and guide therapeutic, site-specific intervention with predictable results. In this article, the various modalities are reviewed in terms of their capability to effectively diagnose and guide treatment of OSA.
Predicting which patients will benefit from surgery for obstructive sleep apnea: the ENT exam. [2005]Airway evaluation is critical for surgical decision making. In patients with obstructive sleep apnea (OSA), a minimal evaluation should include a basic head and neck physical examination to evaluate for overt pathology. An upper airway examination will also provide insight into identifying patients with a higher risk of OSA. For patients who are evaluated for surgery, endoscopy combined with cephalometrics is the most accepted method of identifying patients with retroglossal collapse and obstruction. A new paradigm suggests that most patients have multilevel obstruction, so examination should be directed at assessing risk factors to direct the aggressiveness of surgical intervention.
Role of portable sleep studies for diagnosis of obstructive sleep apnea. [2019]There is growing awareness of the significance of obstructive sleep apnea in the general population and in the medical community and, as a result, there is a growing demand for diagnosis and treatment. Attended, in-laboratory polysomnography is resource intensive and not readily available in some communities. Alternate diagnostic strategies have been proposed including the use of home sleep studies. Although these portable systems have been in use for many years, only in the past few years have a significant number of studies been performed to evaluate these systems in the home setting. The use of actigraphy and peripheral arterial tonometry for diagnostic purposes has also recently been investigated.
Surgical treatment of obstructive sleep apnea syndrome (OSAS) [2004]Obstructive sleep apnea syndrome patients usually present with multiple areas of anatomic disproportions. The site or sites of obstruction must be accurately diagnosed preoperatively by a systematic means of examining the patient. This includes nasopharyngoscopy with Muller maneuver and sometimes cephalometrics. The surgical treatment is individualized to the site or sites of obstruction and can include tracheostomy, septoplasty, UPPP, geniohyoid advancement and suspension of the hyoid. For extreme cases advancement of the maxilla, mandible and hyoid bone are sometimes necessary.
Sleep studies. Current techniques and future trends. [2019]Diagnosis of obstructive sleep apnea has been termed a laboratory diagnosis rather than a clinical diagnosis because one may not be able to make the diagnosis based on the history and physical examination alone. The polysomnogram was developed to give clinicians and researchers objective data on physiologic events occurring during the patient's sleep. From this, obstructive breathing patterns can be diagnosed and if pathologic, appropriate treatment can be instituted. Although the polysomnogram has been the gold standard for diagnosis for more than two decades, it is an expensive and time-consuming procedure. Current technologies for polysomnogram are reviewed, as well as proposals for alternatives that may be more cost and time effective.