Obstructive Sleep Apnea of Adult
Conditions
Brief summary
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
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.
Interventions
DEVICECryosa Procedure
Cryotherapy
Sponsors
Cryosa, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. To participate in this study, the subject must meet ALL of the following inclusion criteria: 2. Age 22 - 70 years 3. Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) if using, must be \< 4 hours per night, \< 5 days/week. 4. Failed, are not candidates for, or have refused other invasive procedures such as hypoglossal nerve stimulation or pharmacotherapy for the primary treatment of OSA such as Tirzepatide. 5. BMI ≥30 or ≤ 40 kg/m2 at enrollment 6. AHI ≥30 at enrollment based on in-lab polysomnography study OR AHI ≥ 15 and BMI of ≥ 30 at enrollment based on in-lab polysomnography study Is geographically stable and in close proximity to the site 7. Able and willing to provide written consent to participate in the study
Exclusion criteria
1. 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 2. Actively taking ACEs/ARBs 3. Actively undergoing immunotherapy (Allergy shots)\*, or unwilling to washout of allergy shots at least 2 weeks prior to study procedure. \* Patients receiving immunotherapy may be eligible if they undergo a 2-week wash-out prior to the study procedure 4. Severe uncontrolled asthma 5. Severe maxillary mandibular insufficiency that in the opinion of the investigator thought to be the primary cause of OSA 6. Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction) 7. Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils). 8. Oral cancer or non-healing oral wounds 9. Prior sleep surgeries, including tongue base reduction, UPPP and hypoglossal nerve stimulation. 10. History of radiation therapy to neck or upper respiratory tract 11. Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy) 12. History presence of cold urticaria at the time of screening History of cryoglobulinemia 13. History of allergy to glycerin 14. History of hospitalization with mechanical ventilation due to COVID-19 per investigator discretion 15. 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 16. Patients with diagnosed autoimmune disorders including thyroid disease, lupus, multiple myeloma, chronic lymphocytic leukemia 17. Neuromuscular disease or other neurologic deficits (for example multiple sclerosis, muscular dystrophy, Parkinson's disease, transient ischemic attack, epilepsy or cerebrovascular accident) 18. Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD) 19. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism) History of angioedema of the airway 20. Hereditary angioedema and other autoimmune disorders that could lead to acquired angioedema - confirmed with a compliment component C4 blood test \<13mg/dL. 21. Uncontrolled Diabetes (including Diabetes Mellitus \[DM\] or Insulin Dependent Diabetes Mellitus \[IDDM\]) with HbA1c \>9. 22. 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 23. Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months 24. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months 25. History or current clinical evidence of TIA or stroke or muscular dysfunction 26. Current smoker (≥ 1 pack/day) 27. Presence of occupational shift work or anticipation of shift changes during the next 2 years 28. Subject has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG and/or HSAT 29. Known active substance use disorder 30. 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 31. 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) 32. 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 33. Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date) 34. Any other reason the investigator deems subject is unfit for participation in the study 35. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Procedure or Device/ Treatment Related Events | First 90 days post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Testing | 6 Month Follow-up Visit | 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. |
| Patient Reported Outcomes (PRO) Efficacy Measures - Epworth Sleepiness Survey (ESS) | 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure | Evaluate change in daytime sleepiness after treatment compared to baseline. |
| Patient Reported Outcomes (PRO) Safety Measures - Pain Numeric Scale (NRS) | 7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure | Evaluate oropharyngeal pain metrics after treatment compared to baseline. |
| Patient Reported Outcomes (PRO) Safety Measures - Eating Assessment Tool (EAT-10) | 7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure | Evaluate change in swallowing metrics after treatment compared to baseline. |
| Patient Reported Outcomes (PRO) Safety Measures - PROMIS-Sleep Disturbance (PROMIS-SD) | 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure | Assess perception of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness |
| Patient Reported Outcomes (PRO) Safety Measures - PROMIS-Sleep Related Impairment (PROMIS-SRI) | 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure | Assess a range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles |
Countries
United States
Outcome results
None listed