Back to results

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

Primary Purpose

Obstructive Sleep Apnea of Adult

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

CHILLS Procedure

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea of Adult

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Paitilla Medical Center
Sanatorio Americano

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

CHILLS Procedure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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)

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)

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)

Full Information

NCT ID

NCT04864652

First Posted

March 17, 2021

Last Updated

September 13, 2022

Sponsor

Cryosa, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04864652

Brief Title

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

Acronym

ARCTIC-1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 30, 2020 (Actual)

Primary Completion Date

September 15, 2023 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cryosa, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea of Adult

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Arm Description

CHILLS Procedure

Intervention Type

Device

Intervention Name(s)

CHILLS Procedure

Intervention Description

CHILLS Cryotherapy procedure

Primary Outcome Measure Information:

Title

Incidence of Serious Procedure-Related Complications

Description

Time Frame

30 Days

Secondary Outcome Measure Information:

Title

Impact of Cryotherapy on Tongue Function: Taste

Description

Evaluated by assessment of change (Definitely, Somewhat, Not at all) to the taste of: salt, sourness, sweetness, bitterness, savory.

Time Frame

7 days, 30 days and 90 days

Title

Impact of Cryotherapy on Tongue Function: Sensation

Description

Time Frame

7 days, 30 days and 90 days

Title

Impact of Cryotherapy on Tongue Function: Movement

Description

Time Frame

7 days, 30 days and 90 days

Title

Impact of Cryotherapy on Tongue Function: Swallowing

Description

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)

Time Frame

7 days, 30 days and 90 days

Other Pre-specified Outcome Measures:

Title

Exploratory Measures: Home Sleep Apnea Testing (HSAT)

Description

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.

Time Frame

90 days

Title

Exploratory Measures: Magnetic Resonance Image (MRI)

Description

An MRI image for fat quantitation without contrast will be collected to evaluate the fat content (% fat) in the treated zone.

Time Frame

45 and 90 days

Title

Exploratory Measures: Patient Reported Outcome Measures

Description

Pain Visual Analog Scale (VAS) with ratings from 0 to 10; 0 being no pain and 10 is the worst possible pain.

Time Frame

2 days, 3 days, 7 days, 30 days, 45 and 90 days

Title

Exploratory Measures: Patient Reported Outcome Measures

Description

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.

Time Frame

30 and 90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marquito Caballero, MD

Organizational Affiliation

Sanatorio Americano

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stella Rowley, MD

Organizational Affiliation

San Fernando Specialized Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Paitilla Medical Center

City

Panama City

Country

Panama

Facility Name

Sanatorio Americano

City

Asunción

Country

Paraguay

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs