Overview

This trial is active, not recruiting.

Condition obstructive sleep apnea
Treatment trans nasal insuflation (tni) [nasal canula]
Sponsor Johns Hopkins University
Start date July 2004
Trial size 100 participants
Trial identifier NCT00832026, NA_00019483

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional
Arm
Patients with diagnosed obstructive sleep apnea
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.

Primary Outcomes

Measure
Change in inspiratory airflow
time frame: 2 nights

Secondary Outcomes

Measure
Change in sleep apnea severity (AHI)
time frame: 2 nights
Change in Ratio of apnea-to-hypopnea events
time frame: 2-nights

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Trans Nasal Insuflation for the Treatment of Snoring and Obstructive Sleep Apnea
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by Johns Hopkins University.