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Procedure

Cryosa Procedure for Obstructive Sleep Apnea (ARCTIC-3 Trial)

N/A

Recruiting

Research Sponsored by Cryosa, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD)

Age 22 - 70 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month follow-up visit

Awards & highlights

ARCTIC-3 Trial Summary

This trial evaluates the safety and performance of a new treatment for moderate-severe OSA. It will also collect data to prove its effectiveness.

Who is the study for?

Adults aged 22-70 with moderate to severe obstructive sleep apnea who can't or won't use PAP or MAD devices, have a BMI of ≤ 40 kg/m2, and are non-smokers. They must be able to consent and live near the study site. Exclusions include general anesthesia risks, recent upper airway surgery, resistant hypertension, certain heart conditions, neuromuscular diseases, active severe lung disease including COVID-19 complications.Check my eligibility

What is being tested?

The Cryosa procedure is being tested for safety and effectiveness in treating obstructive sleep apnea (OSA). This single-arm study involves participants with moderate to severe OSA who will undergo the procedure and then be monitored to assess its performance over time.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include those commonly associated with medical procedures such as pain at the treatment site, swelling, infection risk from wounds or general anesthesia-related complications.

ARCTIC-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot or will not use devices like CPAP or mouthpieces for sleep apnea.

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I am between 22 and 70 years old.

ARCTIC-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month follow-up visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 month follow-up visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month follow-up visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Serious Procedure or Device/ Treatment Related Events

Secondary outcome measures

Patient Reported Outcomes (PRO) Efficacy Measures - Epworth Sleepiness Survey (ESS)

Patient Reported Outcomes (PRO) Efficacy Measures - Functional Outcomes of Sleep Questionnaire (FOSQ)

Patient Reported Outcomes (PRO) Safety Measures - Eating Assessment Tool (EAT-10)

+2 more

Other outcome measures

Home Sleep Apnea Testing (HSAT) - Apnea-Hypopnea Index (AHI4)

Home Sleep Apnea Testing (HSAT) - Hypoxic Burden

Home Sleep Apnea Testing (HSAT) - Oxygen Desaturation Index (ODI)

+2 more

ARCTIC-3 Trial Design

1Treatment groups

Experimental Treatment

Group I: Cryosa ProcedureExperimental Treatment1 Intervention

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).

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Cryosa, Inc.Lead Sponsor

2 Previous Clinical Trials

120 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research protocol have an age limit, and if so, what is it?

"This clinical trial has an age requirement wherein enrollees cannot be younger than 22 nor older than 70."

Answered by AI

Am I eligible to volunteer for this medical experiment?

"In order to qualify for this clinical trial, prospective applicants must have obstructive sleep apnea and be within the ages of 22 up to 70. The study is currently accepting 25 individuals in total."

Answered by AI

Is this investigation currently seeking participants?

"Per the information on clinicaltrials.gov, this experiment is not presently taking part in patient recruitment efforts. The initial posting was made September 12th 2023 and it has been amended for the last time on August 18th 2023. Although no enrolment is happening now, there are 275 additional trials currently hunting for volunteers to partake."

Answered by AI