Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea

Study Overview
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Brief Summary
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This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe OSA. The study will also evaluate the chronic performance of the Cryosa system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.

Detailed Description
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The study will treat 25 subjects enrolled at up to 10 sites in the United States. Enrollment is competitive but each site will be limited to 15 subjects treated.

Official Title
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Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea of Adult

Intervention / Treatment
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* Device: Cryosa Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 22 - 70 years Likely suffer moderate to severe OSA based on history and physical or have an established diagnosis of moderate to severe OSA (AHI ≥ 15) based on a prior sleep study. PSG will be performed after enrollment, or an acceptable PSG performed within 3 months of enrollment is required, to verify a) AHI ≥ 15 b) mixed and central apneas total ≤ 25% of apneas, and c) SpO2 must be ≥ 70% for ≥ 90% of sleep time for continued eligibility. Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) BMI of ≤ 40 kg/m2 at enrollment Is geographically stable and in close proximity to the site Able and willing to provide written consent to participate in the study Exclusion Criteria: Contraindication to general anesthesia or in the opinion of the Investigator would not be able to tolerate the procedure, including intubation during the procedure or in response to an adverse event Severe maxillary mandibular insufficiency that in the opinion of the investigator thought to be the primary cause of OSA Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction) Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils). Oral cancer or non-healing oral wounds Prior sleep surgeries, including tongue base reduction, UPPP and hypoglossal nerve stimulation. History of radiation therapy to neck or upper respiratory tract Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy) History of cold urticaria History of hospitalization with mechanical ventilation due to COVID-19 per investigator discretion Resistant hypertension defined as a blood pressure that remains above goal despite concurrent use of three antihypertensive agents of different classes taken at maximally tolerated doses Neuromuscular disease or other neurologic deficits (for example multiple sclerosis, muscular dystrophy, Parkinson's disease, transient ischemic attack, epilepsy or cerebrovascular accident) Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD) Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism) Untreated, active thyroid disease such as Hashimoto Thyroiditis that may cause angioedema or enlargement of the tongue History of angioedema of the tongue Uncontrolled Diabetes (including Diabetes Mellitus [DM] or Insulin Dependent Diabetes Mellitus [IDDM]) with HbA1c >9. Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (< 12 months) myocardial infarction or severe cardiac arrhythmias Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months History or current clinical evidence of TIA or stroke or muscular dysfunction Current smoker (≥ 1 pack/day) Presence of occupational shift work or anticipation of shift changes during the next 2 years Subject has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG and/or HSAT Known active substance use disorder Other severe sleep disorders that in the opinion of the investigator, confound functional assessments of sleepiness such as narcolepsy with cataplexy, severe insomnia/insomnia secondary to chronic pain, PTSD Patients taking any of the following medication that could affect study endpoints: benzodiazepines, Z-drugs (zolpidem and eszopiclone) opiates, antipsychotics (neuroleptics), phenothiazines, and prescription stimulants (including Sunosi, Provigil, and Nuvigil) Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject's ability to meet study requirements and ability to provide study consent Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date) Any other reason the investigator deems subject is unfit for participation in the study Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryosa Procedure<br>The purpose of this study is to evaluate the safety and effectiveness of Cryosa System applied to the tongue and soft palate in patients with clinically diagnosed obstructive sleep apnea (OSA). | Device: Cryosa Procedure<br>* Cryotherapy<br>* Other names: OSA Cryotreatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Serious Procedure or Device/ Treatment Related Events | Safety will be assessed by evaluating all serious procedure- or device/treatment-related events occurring in the first 90 days post-procedure. Adverse events (AE), both serious and non-serious, related and unrelated, will be collected from all subjects enrolled for the duration of the study. | First 90 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Testing | Quantify the effect of the Cryosa procedure in reducing the severity of OSA post-procedure by evaluating the change from baseline in the apnea hypopnea index (AHI4) with polysomnography (PSG) testing. | 6 Month Follow-up Visit | 
| Patient Reported Outcomes (PRO) Efficacy Measures - Epworth Sleepiness Survey (ESS) | Evaluate change in daytime sleepiness after treatment compared to baseline. | 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure | 
| Patient Reported Outcomes (PRO) Efficacy Measures - Functional Outcomes of Sleep Questionnaire (FOSQ) | Evaluate the change of impact of daytime sleepiness on activities of daily living after treatment compared to baseline. | 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure | 
| Patient Reported Outcomes (PRO) Safety Measures - Pain Numeric Scale (NRS) | Evaluate oropharyngeal pain metrics after treatment compared to baseline. | 7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure | 
| Patient Reported Outcomes (PRO) Safety Measures - Eating Assessment Tool (EAT-10) | Evaluate change in swallowing metrics after treatment compared to baseline. | 7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure |