Clinical trial NCT06008626: Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea
Official title: Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Cryosa, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 25
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 22 - 70 years
2. 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.
3. Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD)
4. BMI of ≤ 40 kg/m2 at enrollment
5. Is geographically stable and in close proximity to the site
6. 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. Severe maxillary mandibular insufficiency that in the opinion of the investigator thought to be the primary cause of OSA
3. Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction)
4. Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils).
5. Oral cancer or non-healing oral wounds
6. Prior sleep surgeries, including tongue base reduction, UPPP and hypoglossal nerve stimulation.
7. History of radiation therapy to neck or upper respiratory tract
8. Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy)
9. History of cold urticaria
10. History of hospitalization with mechanical ventilation due to COVID-19 per investigator discretion
11. 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
12. Neuromuscular disease or other neurologic deficits (for example multiple sclerosis, muscular dystrophy, Parkinson's disease, transient ischemic attack, epilepsy or cerebrovascular accident)
13. Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)
14. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism)
15. Untreated, active thyroid disease such as Hashimoto Thyroiditis that may cause angioedema or enlargement of the tongue
16. History of angioedema of the tongue
17. Uncontrolled Diabetes (including Diabetes Mellitus \[DM\] or Insulin Dependent Diabetes Mellitus \[IDDM\]) with HbA1c \>9.
18. 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
19. Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months
20. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months
21. History or current clinical evidence of TIA or stroke or muscular dysfunction
22. Current smoker (≥ 1 pack/day)
23. Presence of occupational shift work or anticipation of shift changes during the next 2 years
24. Subject has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG and/or HSAT
25. Known active substance use disorder
26. 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
27. 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)
28. 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
29. Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date)
30. Any other reason the investigator deems subject is unfit for participation in the study
31. Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing

Primary outcomes:
measure: Incidence of Serious Procedure or Device/ Treatment Related Events
timeFrame: First 90 days post-procedure
Secondary outcomes:
measure: Sleep Testing
timeFrame: 6 Month Follow-up Visit
measure: Patient Reported Outcomes (PRO) Efficacy Measures - Epworth Sleepiness Survey (ESS)
timeFrame: 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
measure: Patient Reported Outcomes (PRO) Efficacy Measures - Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
measure: Patient Reported Outcomes (PRO) Safety Measures - Pain Numeric Scale (NRS)
timeFrame: 7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
measure: Patient Reported Outcomes (PRO) Safety Measures - Eating Assessment Tool (EAT-10)
timeFrame: 7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
Other outcomes:
measure: Home Sleep Apnea Testing (HSAT) - Apnea-Hypopnea Index (AHI4)
timeFrame: 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
measure: Home Sleep Apnea Testing (HSAT) - Oxygen Desaturation Index (ODI)
timeFrame: 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
measure: Home Sleep Apnea Testing (HSAT) - Oxygen Saturation (SpO2)
timeFrame: 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
measure: Home Sleep Apnea Testing (HSAT) - Hypoxic Burden
timeFrame: 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
measure: Home Sleep Apnea Testing (HSAT) - Snoring
timeFrame: 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Albany
country: United States
facility: Albany ENT & Allergy Services
state: New York
city: Bethlehem
country: United States
facility: Specialty Physician Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Health Sciences Center
state: Tennessee
Study officials:
References: