RECRUITING

NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients

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Conditions

Sleep Apnea, Obstructivenasopharyngeal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This pilot study is being done to determine if the nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device can be used in the treatment of OSA in adults. The researchers think that the NPA-OSA device will reduce the number of apneas.

Official Title

NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Continuous Positive Airway Pressure (CPAP) Resistant Adult OSA Patients

Quick Facts

Study Start:2025-03-07
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06677151

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Capacity and willingness to sign consent
  2. * Patient willingness to commit to and complete study over a 30-day time period
  3. * Confirmed diagnosis of moderate to severe OSA (AHI \>= 15)
  4. * OSA caused by upper airway obstruction
  5. * CPAP non-compliant where CPAP compliance is defined as using CPAP for at least 4 hours a night for at least 70% of nights or interest in an alternative sleep apnea therapy
  6. * Adequate manual dexterity to demonstrate ability to self-insert and remove device
  1. * Within 3 months of initiating CPAP use, and actively using CPAP
  2. * Supraglottic airway collapse
  3. * Distal airway stenosis
  4. * Tracheobronchomalacia
  5. * Currently pregnant
  6. * Active COVID-19 infection
  7. * Need for anticoagulative therapy
  8. * Severe nasal allergies
  9. * Bleeding disorder
  10. * More than mild elevation of End-tidal carbon dioxide (ETCO2) or total carbon dioxide (TCO2) values \>60 mmHg for \>10% of sleep time
  11. * Restrictive thoracic disorders
  12. * Silicone, lidocaine, neosynephrine allergy
  13. * Recurrent epistaxis
  14. * Uncontrolled or serious illness, included but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure

Contacts and Locations

Study Contact

Zahra Nourmohammadi, PhD
CONTACT
734 936-9816
znourmoh@med.umich.edu
Louise M O'Brien, PhD
CONTACT
734 647-9064
louiseo@med.umich.edu

Principal Investigator

Louise M O'Brien, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

Michigan Medicine
Ann Arbor, Michigan, 48109
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Louise M O'Brien, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-07
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-03-07
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • nasopharyngeal

Additional Relevant MeSH Terms

  • Sleep Apnea, Obstructive