Clinical Trials Logo
  1. Home
  2. Obstructive Sleep Apnea of Adult
  3. NCT05542082

Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA — ARCTIC-2  

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:
OUS Multicenter Pilot Study of the CHILLS Cryotherapy System for the Treatment of Obstructive Sleep Apnea (ARCTIC-2)

Clinical Trial Summary

This is a prospective, multicenter, non-randomized single-arm safety and efficacy study to: - Collect data to evaluate the safety of CHILLS cryotherapy to treat OSA in patients with moderate to severe disease. - Evaluate the chronic performance of the CHILLS system and collect clinical measures for therapy effectiveness that will be used to demonstrate safety and effectiveness in the next clinical study.

Clinical Trial Description

The study will enroll up to 3 sites in Latin America, enrollment is competitive. Up to 70 subjects will receive treatment and be followed through their 3-month visit. Long-term follow-up will continue every 6 months out to 2 years post-procedure, with an option to follow patients up to 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05542082
Study type Interventional
Source Cryosa, Inc.
Contact Kristine H Selander, M.S.
Phone 17632673202
Email kselander@cryosa.com
Status Recruiting
Phase N/A
Start date August 1, 2022
Completion date April 1, 2027
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05489562 - Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea N/A
Recruiting NCT05717959 - Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device N/A
Recruiting NCT06008626 - Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea N/A
Completed NCT03940781 - Effects of Rehabilitation for Patients With Obstructive Sleep Apnea N/A
Completed NCT03122639 - Endothelial Function in Obstructive Sleep Apnea Early Phase 1
Recruiting NCT05289063 - Vascular Endothelial Dysfunction in Sleep Apnea Phase 1
Not yet recruiting NCT05268471 - Cost-effectiveness Analysis and Conditional Response to the Effect of Positional Devices in Obstructive Sleep Apnea N/A
Active, not recruiting NCT04864652 - Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA N/A
Enrolling by invitation NCT05433883 - The Relationship Between Obstructive Sleep Apnea and Alzheimer's Disease: Evidence and Effectiveness N/A
Recruiting NCT06103630 - Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device N/A
Recruiting NCT06283095 - Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty N/A
Completed NCT03156283 - SleepWell24: An Innovative Smartphone Application to Improve PAP Adherence N/A
Completed NCT03362385 - OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS Patients
Completed NCT04643782 - Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea N/A
Recruiting NCT03463785 - Does Race Make a Difference in Obstructive Sleep Apnea?
Recruiting NCT03618719 - Impact of Intermittent Hypoxia on the Function of the Phagocytes
Completed NCT03048604 - BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA) N/A
Recruiting NCT05290350 - Long COVID-19 Fatigue and Obstructive Sleep Apnea
Recruiting NCT05739617 - Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea N/A
Completed NCT03980158 - Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy