Status:
COMPLETED
Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA
Lead Sponsor:
Cryosa, Inc.
Conditions:
Obstructive Sleep Apnea of Adult
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief Summary
ARCTIC-1 is a safety and dosing study to evaluate procedure tolerability in patients with clinically diagnosed moderate or severe OSA.
Detailed Description
The study is a safety and dose titration study to determine the optimum dose of Cryosa CHILLS cryotherapy in patients with clinically diagnosed moderate or severe OSA. Up to 70 subjects are planned t...
Eligibility Criteria
Inclusion
- Age 25 - 65 years.
- Diagnosed with moderate to severe OSA based on history and physical or have an established diagnosis of OSA (AHI ≥ 15 and ≤ 50) based on a prior sleep study.
- BMI is between 28 kg/m2 and 40 kg/m2 at enrollment.
- Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for COVID-19.
Exclusion
- Subjects with a high percentage of central apneas suggesting heart failure.
- Contraindication to general anesthesia and MRI.
- Metal braces, plate or pieces in the head or jaw that may interfere with MRI.
- Craniofacial abnormality (e.g. retrognathia, micrognathia, etc.) thought to be the primary cause of OSA.
- Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction) .
- Tonsil size ≥ +3.
- 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.
- Presence of symptoms of influenza-like symptoms.
- Contra-indicated for anesthesia or surgery.
- History of surgery affecting the tongue (TORS, semi-glossectomy, RFBOT, MMA, HGNS).
- 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).
- Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis).
- Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).
- Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (\< 12 month) 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 12 months.
- History or current clinical evidence of TIA or stroke or muscular dysfunction.
- Taking medications that in the opinion of the consulting physician may alter consciousness, the pattern of respiration, or sleep architecture, such examples being benzodiazepines, opiates, neuroleptics, prescription stimulants, phenothiazine, or any form of chemical substance abuse.
- History of dementia or active psychiatric disease that may impact study compliance.
- Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date).
- Unable and/or unwilling to comply with study requirements or to provide written informed consent.
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04864652
Start Date
November 30 2020
End Date
May 6 2023
Last Update
June 26 2025
Active Locations (2)
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1
Paitilla Medical Center
Panama City, Panama
2
Sanatorio Americano
Asunción, Paraguay