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Obstructive Sleep Apnea (OSA)NCT07021833

Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (ARCTIC_AUS)

A study testing Cryosa Procedure in people with Obstructive Sleep Apnea (OSA), run by Cryosa, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

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 (OSA)
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
0 participants
Where
No sites listed yet
Study dates
Apr 2026to Feb 2027
Phase
Interventional
Are there results?
None posted in the registry

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

  • Willing and capable of providing informed consent
  • Willing and capable of receiving the study procedure and returning for all follow-up evaluations and sleep studies
  • Willing and capable of completing all questionnaires
  • Age is 22 to 70 years old
  • Not able to use, refuse to use, or intolerant of Positive Airway Pressure (PAP) or Mandibular Advancement Devices (MAD)
  • BMI of ≤ 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

Who cannot join

  • General Exclusions
  • Subject currently participating in other premarket investigational studies unless approved by Sponsor in writing
  • Any reason the investigator deems the subject unfit for participation in the study
  • Concomitant Medication Exclusions
  • Actively taking ACEs/ARBs for hypertension AND is either of black race, of female gender or >65 years of age
  • Actively undergoing immunotherapy (Allergy shots), or unwilling to washout of allergy shots at least 2 weeks prior to study procedure
Show all 57Show fewer
  • 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)
  • Currently on stable GLP-1 medication dosing and unwilling to commit to maintaining that dose until completion of the 6-month assessment post-procedure.
  • Currently titrating GLP-1 medication and unwilling to discontinue use 1 month prior to procedure date and commit to not to re-start until completion of the 6-month assessment post-procedure
  • Medical History Exclusions
  • Prior sleep surgeries, including tongue base reduction or palatoplasty (with exception of tonsillectomy and/or adenoidectomy)
  • Previous surgery (non-OSA) within 12 weeks of scheduled procedure performed on the soft tissue of the upper airway (e.g., uvula, soft palate, or tonsils)
  • Patients with severe, uncontrolled asthma
  • History of angioedema/swelling 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
  • History or presence of cold urticaria at the time of screening
  • History of cryoglobulinemia
  • History of allergy to glycerin
  • Diagnosed autoimmune disorders including active thyroid disease, lupus, multiple myeloma, chronic lymphocytic leukemia
  • Oral cancer or non-healing oral wounds
  • 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)
  • 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
  • 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)
  • 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
  • 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
  • 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
  • Lifestyle / Work
  • Current smoker (≥ 1 pack/day)
  • Presence of occupational shift work or anticipation of shift changes during the study duration
  • Subject has sleep hygiene behavior that is likely to interfere with measurement outcomes during PSG.
  • Known active substance use disorder
  • Females who are pregnant or females of childbearing age with intention to become pregnant during the study period (period defined as ≤ 3 months from treatment date)
  • Unwilling or unable to refrain from and washout use of oral appliances or positional devices for the PSG sleep studies.
  • Unwilling or unable to refrain from use of PAP, oral appliances for OSA, OSA surgery, or medications for OSA from enrollment through the completion of the Month 6 follow-up visit
  • Subject has an occupation for which untreated OSA presents a substantial risk to safety
  • Residing at or is planning to move within 2 years to a location where the subject would no longer be willing or capable of returning for all follow-up evaluations and sleep studies.
  • Upper Airway Exam
  • Severe maxillary mandibular insufficiency that in the opinion of the investigator thought to be the primary cause of OSA
  • Obvious severe fixed upper airway obstructions (tumors, polyps, nasal obstruction)
  • Obstructions identified at the tonsils (palatine tonsils size 3+ or 4+)
  • Lingual tonsils size 4+
  • Friedman tongue position IV
  • Surgical Consult
  • Contraindication to general anesthesia or in the opinion of the Investigator would not be able to tolerate the procedure, including intubation during the procedure
  • Any reason for which, in the judgment of the investigator, the subject is considered to be a poor surgical or study candidate, which may include, but is not limited to: any medical, anatomical, social, or psychological problems that could complicate the procedure and/or recovery from the procedure or could complicate the required procedures and evaluations of the study
  • PSG Exclusion Criteria
  • ≥ 25% Central and mixed apnea and hypopnea events as a proportion of the sum of apnea and hypopnea events per hour
  • Oxygen saturation must be ≥ 70% for ≥ 90% of time during sleep.
  • Non-supine AHI < 10, minimum of 45 minutes non-supine sleep time
  • Failure to complete a 72-hour CPAP washout period before administering the PSG and unwilling to repeat

About this study

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

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 up to 30 subjects at up to 5 sites in Australia.

Being tested
Cryosa Procedure
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

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

  • Cryosa ProcedureDevice

    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).

Study groups in NCT07021833
Study groupRoleWhat they receive
Cryosa ProcedureExperimentalNot described
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

    Measured: 90 days 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 posted15 Jun 2025
  2. Study startApr 2026 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Why it stopped: Sponsor decision. Study withdrawn prior to enrollment of first participant to prioritize initiation of the pivotal trial in the United States.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07021833
Sponsor's protocol ID
12458
Status last verified
Jun 2025
First submitted
6 Jun 2025
Last updated
13 Jul 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 (OSA), run by Cryosa, Inc..

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 57 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: withdrawn, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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: 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 NCT07021833.

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 13 Jul 2026.

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