Is NCT06008626 recruiting in New Orleans, LA?

Yes, NCT06008626 is currently recruiting participants at its New Orleans, LA location. This obstructive sleep apnea of adult clinical trial is actively enrolling qualified participants.

Is participation in this New Orleans clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Obstructive Sleep Apnea of Adult Clinical Trial in New Orleans, LA

Q: How do I join the obstructive sleep apnea of adult clinical trial in New Orleans?

To join this clinical trial in New Orleans, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Obstructive Sleep Apnea of Adult Study in New Orleans

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.

Sponsor: Cryosa, Inc.

Who Can Participate

Inclusion Criteria

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

Exclusion Criteria

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Orleans?

Yes, this clinical trial (NCT06008626) has an active research site in New Orleans, LA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Obstructive Sleep Apnea of Adult Treatment Options in New Orleans, LA

If you're searching for obstructive sleep apnea of adult treatment options in New Orleans, LA, this clinical trial (NCT06008626) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Orleans research site is actively enrolling participants for this clinical trial. You'll receive care from experienced obstructive sleep apnea of adult specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all obstructive sleep apnea of adult clinical trials near you to find additional studies recruiting in your area.

Obstructive Sleep Apnea of Adult Clinical Trial in New Orleans, LA

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