BridgeMD
New treatment option for Obstructive Sleep Apnea of Adult
Official title Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT06008626
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- To participate in this study, the subject must meet ALL of the following
- 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...
- Failed, are not candidates for, or have refused other invasive procedures such as hypoglossal nerve stimulation or pharmacotherapy for the primary...
- BMI ≥30 or ≤ 40 kg/m2 at enrollment
You likely can't join if
- Contraindication to general anesthesia or in the opinion of the Investigator would not be able to tolerate the procedure, including intubation during...
- 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...
- 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)
See the full eligibility criteria
Who can join
- To participate in this study, the subject must meet ALL of the following
- 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
What rules you out
- 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...
- 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
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Albany, New York, United States
- Bethlehem, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Miami, Florida, United States; Chicago, Illinois, United States; New Orleans, Louisiana, United States; Albany, New York, United States; Bethlehem, Pennsylvania, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.