ARCTIC-3: Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cryosa Procedure 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
Cryotherapy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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) Efficacy Measures - Functional Outcomes of Sleep Questionnaire (FOSQ) [30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure]
Evaluate the change of impact of daytime sleepiness on activities of daily living 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.
Other Outcome Measures
- Home Sleep Apnea Testing (HSAT) - Apnea-Hypopnea Index (AHI4) [90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure]
Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in AHI4 after treatment compared to baseline.
- Home Sleep Apnea Testing (HSAT) - Oxygen Desaturation Index (ODI) [90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure]
Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in ODI sleep metrics after treatment compared to baseline.
- Home Sleep Apnea Testing (HSAT) - Oxygen Saturation (SpO2) [90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure]
Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in SpO2 sleep metrics after treatment compared to baseline.
- Home Sleep Apnea Testing (HSAT) - Hypoxic Burden [90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure]
Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in hypoxic burden sleep metrics after treatment compared to baseline.
- Home Sleep Apnea Testing (HSAT) - Snoring [90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure]
Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in snoring episodes sleep metrics after treatment compared to baseline.
Eligibility Criteria
Criteria
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.
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Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD)
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BMI of ≤ 40 kg/m2 at enrollment
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Is geographically stable and in close proximity to the site
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Able and willing to provide written consent to participate in the study
Exclusion Criteria:
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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
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Severe maxillary mandibular insufficiency that in the opinion of the investigator thought to be the primary cause of OSA
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Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction)
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Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils).
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Oral cancer or non-healing oral wounds
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Prior sleep surgeries, including tongue base reduction, UPPP and hypoglossal nerve stimulation.
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History of radiation therapy to neck or upper respiratory tract
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Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy)
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History of cold urticaria
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History of hospitalization with mechanical ventilation due to COVID-19 per investigator discretion
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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
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Neuromuscular disease or other neurologic deficits (for example multiple sclerosis, muscular dystrophy, Parkinson's disease, transient ischemic attack, epilepsy or cerebrovascular accident)
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Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)
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Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism)
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Untreated, active thyroid disease such as Hashimoto Thyroiditis that may cause angioedema or enlargement of the tongue
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History of angioedema of the tongue
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Uncontrolled Diabetes (including Diabetes Mellitus [DM] or Insulin Dependent Diabetes Mellitus [IDDM]) with HbA1c >9.
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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
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Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months
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Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months
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History or current clinical evidence of TIA or stroke or muscular dysfunction
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Current smoker (≥ 1 pack/day)
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Presence of occupational shift work or anticipation of shift changes during the next 2 years
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Subject has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG and/or HSAT
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Known active substance use disorder
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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
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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)
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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
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Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date)
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Any other reason the investigator deems subject is unfit for participation in the study
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Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Albany ENT & Allergy Services | Albany | New York | United States | 12205 |
Sponsors and Collaborators
- Cryosa, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 11515