Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea
ConditionObstructive Sleep Apnea of Adult
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorCryosa, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Severe uncontrolled asthma
Trial design
Design model
Single group
Treatments tested in this trial
Cryosa Procedure
DeviceCryotherapy
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Cryosa ProcedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
First 90 days post-procedureSecondary outcomes
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.
Time frame
6 Month Follow-up Visit2
Patient Reported Outcomes (PRO) Efficacy Measures - Epworth Sleepiness Survey (ESS)
Evaluate change in daytime sleepiness after treatment compared to baseline.
Time frame
30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure3
Patient Reported Outcomes (PRO) Safety Measures - Pain Numeric Scale (NRS)
Evaluate oropharyngeal pain metrics after treatment compared to baseline.
Time frame
7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure4
Patient Reported Outcomes (PRO) Safety Measures - Eating Assessment Tool (EAT-10)
Evaluate change in swallowing metrics after treatment compared to baseline.
Time frame
7 Days, 30 Days, 90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedureOther outcomes
1
Home Sleep Apnea Testing (HSAT) - Apnea-Hypopnea Index (AHI4)
Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in AHI4 after treatment compared to baseline.
Time frame
90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure2
Home Sleep Apnea Testing (HSAT) - Oxygen Desaturation Index (ODI)
Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in ODI sleep metrics after treatment compared to baseline.
Time frame
90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure3
Home Sleep Apnea Testing (HSAT) - Oxygen Saturation (SpO2)
Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in SpO2 sleep metrics after treatment compared to baseline.
Time frame
90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedure4
Home Sleep Apnea Testing (HSAT) - Hypoxic Burden
Two nights of testing will be collected, and the average of the two nights will be used to evaluate the change in hypoxic burden sleep metrics after treatment compared to baseline.
Time frame
90 Days, 6 Months, 12 Months, 18 Months and 24 Months Post-procedureSponsors and contacts
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Source ClinicalTrials.gov