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

Overview

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

• Device Cryosa Procedure
  Cryotherapy

Primary outcome measures

• Incidence of Serious Procedure or Device/ Treatment Related Events [Time frame: First 90 days post-procedure]

Secondary outcome measures (6)

• Sleep Testing [Time frame: 6 Month Follow-up Visit]
• Patient Reported Outcomes (PRO) Efficacy Measures - Epworth Sleepiness Survey (ESS) [Time frame: 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) [Time frame: 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) [Time frame: 7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure]
• Patient Reported Outcomes (PRO) Safety Measures - PROMIS-Sleep Disturbance (PROMIS-SD) [Time frame: 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure]
• Patient Reported Outcomes (PRO) Safety Measures - PROMIS-Sleep Related Impairment (PROMIS-SRI) [Time frame: 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure]

Eligibility criteria

Inclusion criteria

• To participate in this study, the subject must meet ALL of the following inclusion criteria:
• Age 22 - 70 years
• 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.
• 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.
• BMI ≥30 or ≤ 40 kg/m2 at enrollment
• 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
• 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
• Actively taking ACEs/ARBs
• 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

• Severe uncontrolled asthma
• 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 presence of cold urticaria at the time of screening History of cryoglobulinemia
• History of allergy to glycerin
• 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
• Patients with diagnosed autoimmune disorders including thyroid disease, lupus, multiple myeloma, chronic lymphocytic leukemia
• 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) History of angioedema of the airway
• Hereditary angioedema and other autoimmune disorders that could lead to acquired angioedema - confirmed with a compliment component C4 blood test <13mg/dL.
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 9 centers

• UCHealth University of Colorado — Aurora
• University of Miami — Miami
• Rush University Medical Center — Chicago
• Ochsner Baptist Medical Center — New Orleans
• Albany ENT & Allergy Services — Albany
• Specialty Physician Associates — Bethlehem
• University of Pennsylvania — Philadelphia
• University of Tennessee Health Sciences Center — Memphis
• … and 1 more center

Identifiers

NCT: NCT06008626 · 11515

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗