Imaging Predictors of Cryolysis Efficacy for Treatment of Obstructive Sleep Apnea

NCT06434558 | Enrolling By Invitation DMC

• 1 other identifier: 855200
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to further evaluate the efficacy and mechanism of action of the Cryosa Procedure, a novel procedure intended to treat obstructive sleep apnea (OSA). The patient population includes participants with OSA who are enrolled in the ARCTIC-3 study and are undergoing the Cryosa Procedure. The main questions to be answered are: (1) evaluate predictors of successful treatment with the Cryosa Procedure, which is described in more detail in the ARCTIC-3 protocol (IRB #854182), and (2) evaluate a potential mechanism of action of this novel therapy. The study team hypothesizes that higher baseline quantities of oropharyngeal fat and higher baseline upper airway neurotonic activity will be correlated with a successful reduction in OSA symptom severity as measured by a change in apnea-hypopnea index values. The study team also hypothesizes that responders will have a decrease in oropharyngeal fat, which would indicate the mechanism of action of this novel therapy is a loss in oropharyngeal fat. Participants will be asked to:

1. 1.have an MRI before undergoing the Cryosa Procedure
2. 2.have an ultrasound before the Cryosa Procedure
3. 3.permit the use of pressure-sensing catheters and ultrasound during their drug-induced sleep endoscopy, which is part of the ARCTIC-3 protocol
4. 4.have an MRI after the Cryosa Procedure
5. 5.have an ultrasound after the Cryosa Procedure.

Conditions

Obstructive Sleep Apnea of Adult

Keywords

Obstructive Sleep Apnea; ultrasound; MRI; cryotherapy

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Oropharyngeal Fat at 6 Months

  Quantity of oropharyngeal fat will be measured with magnetic resonance imaging (MRI) before the Cryosa Procedure and 6 months after the Cryosa Procedure in all subject participants.

  Baseline and 6 months

• Change in Baseline Apnea Hypopnea Index at 6 Months

  All participants in this study, who are also enrolled in the ARCTIC-3 study, are undergoing a polysomnogram as part of the ARCTIC-3 study at baseline and at 6 months. AHI is measured during these sleep studies in every patient at both timepoints.

  Baseline and 6 Months

Interventions

Cryosa Procedure PROCEDURE

The Cryosa Procedure is part of the ARCTIC-3 protocol (IRB #854182). Therefore, all patients enrolled in this study are expected to undergo the Cryosa Procedure. Undergoing the Cryosa Procedure is not a part of this protocol.

Also known as: Cryotherapy, OSA Cryotreatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study enrolls only participants that are previously enrolled in the ARCTIC-3 trial and are subsequently undergoing the Cryosa Procedure as part of the ARCTIC-3 protocol. As required by the eligibility criteria in the ARCTIC-3 study, these patients have a BMI less than or equal to 40 kg/m2, are 22 to 70 years old, and have moderate to severe obstructive sleep apnea (OSA). Additionally, eligibility requirements from the ARCTIC-3 trial include having never previously undergone uvulopalatopharyngoplasty or tongue base reduction for the treatment of OSA. Patients are also excluded for any other reasons the principal investigator would deem a contraindication to undergoing procedures outlined by the ARCTIC-3 protocol.

You may qualify if:

• Enrolled in the ARCTIC-3 clinical trial at the University of Pennsylvania\*
• Provision of signed and dated informed consent form for ICE-OSA

You may not qualify if:

• MRI contraindications (claustrophobia, ferromagnetic implants/foreign bodies, etc.)
• Patient is pregnant or becomes pregnant during their enrollment

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Raj Dedhia, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Otorhinolaryngology & Medicine | Director, Division of Sleep Surgery & CPAP Alternatives Clinic

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: June 12, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2030
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)