Clinical trial NCT04864652: Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA
Official title: Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of Obstructive Sleep Apnea (OSA): ARCTIC-1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Cryosa, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 70
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 to be enrolled and treated with the device at up to 3 clinical sites in Latin America. Subjects will be followed for 90 days with evaluation intervals at discharge, 7 days, 30 days and 90 days post-procedure. Subjects agreeing to long-term follow-up will complete visits every 6 months through 2 years post-procedure.

Eligibility criteria: Inclusion Criteria:

1. Age 25 - 65 years.
2. 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.
3. BMI is between 28 kg/m2 and 40 kg/m2 at enrollment.
4. Negative result for COVID-19 polymerase chain reaction (RT-PCR) test and absence of clinical symptoms for COVID-19.

Exclusion Criteria:

1. Subjects with a high percentage of central apneas suggesting heart failure.
2. Contraindication to general anesthesia and MRI.
3. Metal braces, plate or pieces in the head or jaw that may interfere with MRI.
4. Craniofacial abnormality (e.g. retrognathia, micrognathia, etc.) thought to be the primary cause of OSA.
5. Obvious fixed upper airway obstructions (tumors, polyps, nasal obstruction) .
6. Tonsil size ≥ +3.
7. Previous surgery within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate or tonsils).
8. Oral cancer or non-healing oral wounds.
9. Presence of symptoms of influenza-like symptoms.
10. Contra-indicated for anesthesia or surgery.
11. History of surgery affecting the tongue (TORS, semi-glossectomy, RFBOT, MMA, HGNS).
12. History of radiation therapy to neck or upper respiratory tract
13. Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat (with exception of tonsillectomy and/or adenoidectomy).
14. Clinical evidence of severe chronic obstructive or restrictive pulmonary disease (for example chronic bronchitis, emphysema, pulmonary fibrosis).
15. Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism).
16. 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.
17. Subjects with bleeding event, known bleeding diathesis, impaired immunity for any reason, or heart attack or stroke within the last 12 months.
18. Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 12 months.
19. History or current clinical evidence of TIA or stroke or muscular dysfunction.
20. 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.
21. History of dementia or active psychiatric disease that may impact study compliance.
22. Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date).
23. Unable and/or unwilling to comply with study requirements or to provide written informed consent.

Primary outcomes:
measure: Incidence of Serious Procedure-Related Complications
timeFrame: 30 Days
Secondary outcomes:
measure: Impact of Cryotherapy on Tongue Function: Taste
timeFrame: 7 days, 30 days and 90 days
measure: Impact of Cryotherapy on Tongue Function: Sensation
timeFrame: 7 days, 30 days and 90 days
measure: Impact of Cryotherapy on Tongue Function: Movement
timeFrame: 7 days, 30 days and 90 days
measure: Impact of Cryotherapy on Tongue Function: Swallowing
timeFrame: 7 days, 30 days and 90 days
Other outcomes:
measure: Exploratory Measures: Home Sleep Apnea Testing (HSAT)
timeFrame: 90 days
measure: Exploratory Measures: Magnetic Resonance Image (MRI)
timeFrame: 45 and 90 days
measure: Exploratory Measures: Patient Reported Outcome Measures
timeFrame: 2 days, 3 days, 7 days, 30 days, 45 and 90 days
measure: Exploratory Measures: Patient Reported Outcome Measures
timeFrame: 30 and 90 days
Locations:
city: Panama City
country: Panama
facility: Paitilla Medical Center
city: Asunción
country: Paraguay
facility: Sanatorio Americano
Study officials:
affiliation: Sanatorio Americano
name: Marquito Caballero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Fernando Specialized Center
name: Stella Rowley, MD
role: PRINCIPAL_INVESTIGATOR
References: