Trans Nasal Insuflation for the Treatment of Snoring

Brief Summary

Official Title: “Trans Nasal Insuflation for the Treatment of Snoring and Obstructive Sleep Apnea”

This research is being done to examine if a nasal cannula can be used to keep the throat open during sleep, thereby treating sleep apnea.

People with sleep apnea and people who snore without sleep apnea may take part in this study. Sleep apnea is a disorder caused by pauses in breathing due to repetitive closure of the throat. The most common form of treatment for sleep apnea is continuous positive airway pressure (CPAP) therapy. While CPAP therapy remains the simplest and most effective treatment for snoring and sleep apnea, patients have to wear a nasal mask throughout the night. For this reason, patients often have difficulty sticking to therapy.

Participants enrolled in this study will spend 3-nights in a sleep laboratory. In all nights, the investigators will monitor your sleep and your breathing throughout the night. The investigators will apply several electrodes (sensors) to your scalp and face to monitor your sleep and breathing, and other sensors to your chest, abdomen, cheek, and a finger to monitor your breathing and oxygen level.

  • Study Type: Observational
  • Study Design: Observational Model: Case-Only, Time Perspective: Cross-Sectional

Interventions Used in this Clinical Trial

  • Device: Trans Nasal Insuflation (TNI) [nasal canula]
    • Trans Nasal Insuflation, or TNI, uses air at flow rates delivered through a small nasal canula to reduce the severity and frequency of sleep apnea events. By using TNI we hope to increase the amount of air that the patient can breathe during periods of obstructive sleep disordered breathing.

Arms, Groups and Cohorts in this Clinical Trial

  • Sleep apnea
    • Patients with diagnosed obstructive sleep apnea

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in inspiratory airflow
    • Time Frame: 2 nights
      Safety Issue?: No

Secondary Measures

  • Change in sleep apnea severity (AHI)
    • Time Frame: 2 nights
      Safety Issue?: No
  • Change in Ratio of apnea-to-hypopnea events
    • Time Frame: 2-nights
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Consenting adults over the age of 21
  • Diagnosed obstructive sleep apnea

Exclusion Criteria

  • Unstable cardiovascular disease;
  • Uncontrolled hypertension (BP > 190/110);
  • Severe intrinsic lung diseases (supplemental O2 > 2 L/min during the day);
  • History of chronic renal insufficiency;
  • History of hepatic insufficiency;
  • Pregnancy;
  • Bleeding disorders or Coumadin use;
  • Sleep Disorders other than OSA;
  • Tracheostomy;
  • Allergy to lidocaine

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Johns Hopkins University
  • Provider of Information About this Clinical Study
    • Hartmut Schneider, Johns Hopkins University

Citations Reporting on Results

McGinley BM, Patil SP, Kirkness JP, Smith PL, Schwartz AR, Schneider H. A nasal cannula can be used to treat obstructive sleep apnea. Am J Respir Crit Care Med. 2007 Jul 15;176(2):194-200. Epub 2007 Mar 15.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00832026