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Procedure

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

N/A

Waitlist Available

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

Must not have

Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism)

Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month follow-up visit

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe lung blood vessel problems like high blood pressure in lungs or clots.

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I have severe kidney failure and am on or will need dialysis soon.

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My diabetes is not under control, with an HbA1c level over 9.

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I do not have severe blockages in my upper airway due to tumors or polyps.

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I am not currently being treated for severe heart issues.

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My high blood pressure isn't controlled despite taking three different blood pressure medicines.

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I have oral cancer or wounds in my mouth that won’t heal.

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I have had surgery for sleep issues, like reducing tongue size or stimulating the nerve under my tongue.

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I have a neuromuscular disease or other neurological condition.

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I have had radiation therapy to my neck or upper respiratory area.

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I have been diagnosed with moderate to severe COPD.

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I have had a stroke, TIA, or muscle problems.

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I am not pregnant nor planning to become pregnant within 3 months of treatment.

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I am not taking medications like benzodiazepines, opiates, antipsychotics, or stimulants that could affect the study.

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I haven't had a heart attack, stroke, or major bleeding in the past year.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Serious Procedure or Device/ Treatment Related Events

Secondary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 17Eligibility criteria met