Obstructive Sleep Apnea (OSA), OSA, Sleep Apnea - Obstructive
Conditions
Keywords
OASIS, Crysoa, OSA, Cryotherapy, Obstructive Sleep Apnea
Brief summary
The objective of this study is to evaluate the safety and effectiveness of the Cryosa System when used as intended to perform the Cryosa Procedure.
Detailed description
This is a multi-center, prospective, non-randomized, single-arm clinical trial in adult patients with moderate to severe Obstructive Sleep Apnea (OSA)
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 No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant age is 22 years and older 2. Participant has failed, is unable to use, unwilling to use or dissatisfied with Positive Airway Pressure (PAP) or mandibular advancement devices (MAD) 3. Participant is diagnosed with Obstructive Sleep Apnea with an AHI ≥30 OR AHI ≥ 15 and BMI of ≥ 30 at enrollment (CA/MA ≤ 25%) 4. Participant is willing and capable of receiving the study procedure, completing all the questionnaires and returning for all follow-up evaluations and sleep studies 5. Participant is willing and capable of providing informed consent
Exclusion criteria
1. Participant is currently participating in other premarket investigational studies unless approved by Sponsor in writing 2. Any reason for which, in the judgment of the investigator, the participant is considered to be a poor study candidate, which may include, but is not limited to: any uncontrolled neurological, medical, social, or psychological problems that could complicate the required procedures and evaluations of the study (e.g. uncontrolled Type 1 or 2 diabetes with neuropathy, debilitating acute or chronic cardiac, lung, liver, kidney, central nervous system or psychiatric disease) 3. Participant has a BMI \> 40 kg/m2 at enrollment 4. Women who are pregnant or of childbearing potential (WOCBP defined as fertile following menarche and until becoming post-menopausal unless permanently sterile) who are unwilling to practice an appropriate method of contraception from screening through 6-month follow-up. Concomitant Medication Exclusions 5. Participant is actively taking ACEs/ARBs for hypertension AND is either of black race, of female gender, or \>65 years of age 6. Participant is actively undergoing immunotherapy (Allergy shots), and unwilling to wash out of allergy shots at least 2 weeks prior to study procedure 7. Participant is taking any of the following medications that, in the opinion of the investigator, could affect study endpoints: AD109, benzodiazepines, Z-drugs (zolpidem and eszopiclone), opiates, antipsychotics (neuroleptics), phenothiazines, and prescription stimulants (including Sunosi, Provigil, and Nuvigil) Significant Airway Risk Factors 8. Participants with severe uncontrolled asthma 9. Participants with a history of angioedema 10. Participants with hereditary angioedema (confirmed with a Complement Component C4 blood test \<13mg/dL) 11. Participant has uncontrolled autoimmune disorders including active thyroid disease, lupus, multiple myeloma, and chronic lymphocytic leukemia that could lead to acquired angioedema 12. Participant has a history or presence of cold urticaria at the time of screening 13. Participant has a history of cryoglobulinemia or Paradoxical Adipose Hyperplasia (PAH) 14. Participant has a history of allergy to glycerin History of Oral/Airway Comorbidities/Interventions 15. Participant has a prior airway interventions that alter or excise the tissue of the soft palate or the tongue base 16. Participant has any airway intervention within 12 weeks of scheduled procedure performed to alter or excise the soft tissue of the airway or larynx 17. Participant has an active, implanted, nerve stimulator for the treatment of OSA 18. Participant has oral cancer or non-healing oral wounds 19. Participant has a history of radiation therapy to neck or upper respiratory tract 20. Participant has 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 Major Anatomical Exclusions 21. Participant has severe maxillary mandibular insufficiency or obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction) that, in the opinion of the investigator, is thought to be the primary cause of OSA 22. Participant has obstructions identified at the tonsils (palatine tonsils size 3+ or 4+) 23. Participant has lingual tonsils size 4+ 24. Participant has Friedman tongue position IV 25. Participant has a mandibular intermolar width \< 32mm 26. Participant has trismus as defined by a maximal inter-incisal opening of \< 35mm Significant Comorbidities that Contraindicate Surgery or General Anesthesia 27. Participant has 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 28. Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD) 29. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism). 30. Uncontrolled Diabetes (including Diabetes Mellitus \[DM\] or Insulin Dependent Diabetes Mellitus \[IDDM\]) with HbA1c \>9 at time of screening. 31. 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 32. Participants with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months 33. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months 34. Participant has contraindication to general anesthesia or, in the opinion of the Investigator, would not be able to tolerate the procedure, including intubation during the procedure Lifestyle considerations 35. Participant is a current smoker or nicotine vaper (\>1 pack/day or equivalent) 36. Participant conducts work or regular activities requiring vigilance (e.g., commercial driver, heavy machine operator, shift worker, etc.) that does not accommodate untreated OSA. 37. Participant has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG 38. Participant exhibits ongoing misuse of alcohol or recreational drugs that would impact either the results of or the participation in a sleep study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 6 Months, 12 Months | The safety of the Cryosa System will be assessed via the description of all reported adverse events. Adverse events will be summarized by seriousness, severity and relatedness to the device and/or procedure |
| Primary Co-Efficacy AHI Responder Endpoint | 6 Months | Reduction in AHI of ≥ 50% or 15 points improvement at 6 months compared to baseline. |
| Primary Co-Efficacy ODI Responder Endpoint | 6 Months | Reduction in ODI of ≥ 25% improvement at 6 months compared to baseline. |
Contacts
CONTACTAndrea Stone
CONTACTLaura Stoltenberg
PRINCIPAL_INVESTIGATORB. Tucker Woodson, MD
Medical College Wisconsin
PRINCIPAL_INVESTIGATORMichael J Hutz, MD
Rush University Medical Center
Outcome results
None listed