Trans Nasal Insufflation for the Treatment of Snoring (TNI)
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|ClinicalTrials.gov Identifier: NCT00832026|
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : September 18, 2018
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.
|Condition or disease||Intervention/treatment|
|Obstructive Sleep Apnea||Device: Trans Nasal Insufflation (TNI) [nasal canula]|
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Trans Nasal Insufflation for the Treatment of Snoring and Obstructive Sleep Apnea|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
Patients with diagnosed obstructive sleep apnea
Device: Trans Nasal Insufflation (TNI) [nasal canula]
Trans Nasal Insufflation, 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.
- Change in inspiratory airflow [ Time Frame: 2 nights ]
- Change in sleep apnea severity (AHI) [ Time Frame: 2 nights ]
- Change in Ratio of apnea-to-hypopnea events [ Time Frame: 2-nights ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832026
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21224|