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Obstructive Sleep Apnea of AdultARCTIC-3NCT06008626

Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea

A study testing Cryosa Procedure in people with Obstructive Sleep Apnea of Adult, run by Cryosa, Inc. at 9 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe OSA. Read more about this study

Who is it for?
Ages 22 to 70 years
Conditions the study is for
Obstructive Sleep Apnea of Adult
What is being tested?
Cryosa Procedure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
9 sitesUnited States
Study dates
12 Sep 2023to 30 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To participate in this study, the subject must meet ALL of the following inclusion criteria:
  • Age 22 - 70 years
  • Not able to use, refuse to use or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) if using, must be < 4 hours per night, < 5 days/week.
  • Failed, are not candidates for, or have refused other invasive procedures such as hypoglossal nerve stimulation or pharmacotherapy for the primary treatment of OSA such as Tirzepatide.
  • BMI ≥30 or ≤ 40 kg/m2 at enrollment
  • AHI ≥30 at enrollment based on in-lab polysomnography study OR AHI ≥ 15 and BMI of ≥ 30 at enrollment based on in-lab polysomnography study Is geographically stable and in close proximity to the site
  • Able and willing to provide written consent to participate in the study

Who cannot join

  • Contraindication to general anesthesia or in the opinion of the Investigator would not be able to tolerate the procedure, including intubation during the procedure or in response to an adverse event
  • Actively taking ACEs/ARBs
  • Actively undergoing immunotherapy (Allergy shots)*, or unwilling to washout of allergy shots at least 2 weeks prior to study procedure.
  • Patients receiving immunotherapy may be eligible if they undergo a 2-week wash-out prior to the study procedure
  • Severe uncontrolled asthma
  • Severe maxillary mandibular insufficiency that in the opinion of the investigator thought to be the primary cause of OSA
Show all 36Show fewer
  • Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction)
  • 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
  • Prior sleep surgeries, including tongue base reduction, UPPP and hypoglossal nerve stimulation.
  • 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)
  • History presence of cold urticaria at the time of screening History of cryoglobulinemia
  • History of allergy to glycerin
  • History of hospitalization with mechanical ventilation due to COVID-19 per investigator discretion
  • Resistant hypertension defined as a blood pressure that remains above goal despite concurrent use of three antihypertensive agents of different classes taken at maximally tolerated doses
  • Patients with diagnosed autoimmune disorders including thyroid disease, lupus, multiple myeloma, chronic lymphocytic leukemia
  • Neuromuscular disease or other neurologic deficits (for example multiple sclerosis, muscular dystrophy, Parkinson's disease, transient ischemic attack, epilepsy or cerebrovascular accident)
  • Diagnosis of any moderate to severe congestive obstructive pulmonary disease (COPD)
  • Active, severe pulmonary vascular disease (for example pulmonary arterial hypertension or pulmonary embolism) History of angioedema of the airway
  • Hereditary angioedema and other autoimmune disorders that could lead to acquired angioedema - confirmed with a compliment component C4 blood test <13mg/dL.
  • Uncontrolled Diabetes (including Diabetes Mellitus [DM] or Insulin Dependent Diabetes Mellitus [IDDM]) with HbA1c >9.
  • Currently receiving treatment for severe cardiac valvular dysfunction, NYHA Class III or IV heart failure, unstable angina or recent (< 12 months) 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 6 months
  • History or current clinical evidence of TIA or stroke or muscular dysfunction
  • Current smoker (≥ 1 pack/day)
  • Presence of occupational shift work or anticipation of shift changes during the next 2 years
  • Subject has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG and/or HSAT
  • Known active substance use disorder
  • Other severe sleep disorders that in the opinion of the investigator, confound functional assessments of sleepiness such as narcolepsy with cataplexy, severe insomnia/insomnia secondary to chronic pain, PTSD
  • Patients taking any of the following medication that could affect study endpoints: benzodiazepines, Z-drugs (zolpidem and eszopiclone) opiates, antipsychotics (neuroleptics), phenothiazines, and prescription stimulants (including Sunosi, Provigil, and Nuvigil)
  • Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject's ability to meet study requirements and ability to provide study consent
  • Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (≤ 3 months from treatment date)
  • Any other reason the investigator deems subject is unfit for participation in the study
  • Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Albany ENT & Allergy Services

    Albany, New York, 12205

  • UCHealth University of Colorado

    Aurora, Colorado, 80045

  • Specialty Physician Associates

    Bethlehem, Pennsylvania, 18017

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • University of Tennessee Health Sciences Center

    Memphis, Tennessee, 38163

  • University of Miami

    Miami, Florida, 33136

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Multicenter Pilot Study of the Cryosa System for the Treatment of Obstructive Sleep Apnea

This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe OSA. The study will also evaluate the chronic performance of the Cryosa system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.

Read the detailed description

The study will treat 25 subjects enrolled at up to 10 sites in the United States. Enrollment is competitive but each site will be limited to 15 subjects treated.

Being tested
Cryosa Procedure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cryosa ProcedureDevice

    Also called OSA Cryotreatment

    Cryotherapy

Study groups in NCT06008626
Study groupRoleWhat they receive
Cryosa ProcedureExperimentalThe 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).
Receives: Device: Cryosa Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Serious Procedure or Device/ Treatment Related Events

    Safety will be assessed by evaluating all serious procedure- or device/treatment-related events occurring in the first 90 days post-procedure.

    Adverse events (AE), both serious and non-serious, related and unrelated, will be collected from all subjects enrolled for the duration of the study.

    Measured: First 90 days post-procedure

Secondary outcomes (6)

  1. Sleep Testing

    Quantify the effect of the Cryosa procedure in reducing the severity of OSA post-procedure by evaluating the change from baseline in the apnea hypopnea index (AHI4) with polysomnography (PSG) testing.

    Measured: 6 Month Follow-up Visit

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

    Evaluate change in daytime sleepiness after treatment compared to baseline.

    Measured: 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

  3. Patient Reported Outcomes (PRO) Safety Measures - Pain Numeric Scale (NRS)

    Evaluate oropharyngeal pain metrics after treatment compared to baseline.

    Measured: 7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

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

    Evaluate change in swallowing metrics after treatment compared to baseline.

    Measured: 7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

  5. Patient Reported Outcomes (PRO) Safety Measures - PROMIS-Sleep Disturbance (PROMIS-SD)

    Assess perception of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness

    Measured: 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

  6. Patient Reported Outcomes (PRO) Safety Measures - PROMIS-Sleep Related Impairment (PROMIS-SRI)

    Assess a range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles

    Measured: 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start12 Sep 2023
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion30 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06008626
Sponsor's protocol ID
11515
Acronym
ARCTIC-3
Status last verified
Aug 2026
First submitted
7 Aug 2023
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cryosa Procedure in people with Obstructive Sleep Apnea of Adult, run by Cryosa, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Serious Procedure or Device/ Treatment Related Events (time frame: First 90 days post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06008626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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