Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA

Obstructive Sleep Apnea of Adult Clinical Trial

— ARCTIC-1  

Official title:

Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of Obstructive Sleep Apnea (OSA): ARCTIC-1

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04864652
• Other study ID #: 10419
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2022
• Source: Cryosa, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ARCTIC-1 is a safety and dosing study to evaluate procedure tolerability in patients with clinically diagnosed moderate or severe OSA.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 1, 2024
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CHILLS Procedure
CHILLS Cryotherapy procedure

Locations

Country	Name	City	State
Panama	Paitilla Medical Center	Panama City
Paraguay	Sanatorio Americano	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
Cryosa, Inc.

Countries where clinical trial is conducted

Panama,  Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Measures: Home Sleep Apnea Testing (HSAT)	The feasibility of using a Level 3 home sleep study will be evaluated. Two consecutive nights of home sleep testing will be collected.; The average Apnea Hypopnea Index (AHI) from the 2 nights of recording will be reported.	90 days
Other	Exploratory Measures: Magnetic Resonance Image (MRI)	An MRI image for fat quantitation without contrast will be collected to evaluate the fat content (% fat) in the treated zone.	45 and 90 days
Other	Exploratory Measures: Patient Reported Outcome Measures	Pain Visual Analog Scale (VAS) with ratings from 0 to 10; 0 being no pain and 10 is the worst possible pain.	2 days, 3 days, 7 days, 30 days, 45 and 90 days
Other	Exploratory Measures: Patient Reported Outcome Measures	Epworth Sleepiness Survey (ESS) that rates a daytime sleepiness on a scale of 0 to 22 with 22 being most sleepy as possible during the day. Patients rate on a 4-point scale (0 to 3, where 0 is no change of dozing and 3 a high chance of dozing) their usual chances of having dozed off or fallen asleep while engaged in eight different activities.	30 and 90 days
Primary	Incidence of Serious Procedure-Related Complications	No serious procedure-related complications including death, loss of the airway requiring post-anesthesia care unit (PACU) re-intubation, persistent loss (more than 30 days) of tongue movement, or bleeding requiring surgical intervention or transfusion.	30 Days
Secondary	Impact of Cryotherapy on Tongue Function: Taste	Evaluated by assessment of change (Definitely, Somewhat, Not at all) to the taste of: salt, sourness, sweetness, bitterness, savory.	7 days, 30 days and 90 days
Secondary	Impact of Cryotherapy on Tongue Function: Sensation	Evaluated by assessment of any numbness of the tongue (Yes, No; if Yes: Mild, Mild to Moderate, Moderate, Moderate to Severe, Severe) physical examination, and tests.; Evaluated by assessment of any burning of the tongue (Yes, No; if Yes: Mild, Mild to Moderate, Moderate, Moderate to Severe, Severe)	7 days, 30 days and 90 days
Secondary	Impact of Cryotherapy on Tongue Function: Movement	Evaluated by assessment of tongue movement via standardized physical examination.; Abnormal deviation of the tongue when extended (Yes, No) Difficulty extending the tongue left (Yes, No) Difficulty extending the tongue right(Yes, No) Difficulty extending the tongue up (Yes, No) Difficulty extending the tongue down (Yes, No)	7 days, 30 days and 90 days
Secondary	Impact of Cryotherapy on Tongue Function: Swallowing	Evaluated by Physician observation for overt signs of cough or other difficulty during trial swallows (e.g., water) or routine oral intake (Unremarkable or Abnormal, specify)	7 days, 30 days and 90 days