Trans Nasal Insufflation for the Treatment of Snoring

Study Overview
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Brief Summary
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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.

Official Title
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Trans Nasal Insufflation for the Treatment of Snoring and Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Trans Nasal Insufflation (TNI) [nasal canula]


Participation Criteria
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Eligibility Criteria
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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 Obstructive Sleep Apnea (OSA) Tracheostomy Allergy to lidocaine

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sleep apnea<br>Patients with diagnosed obstructive sleep apnea | Device: Trans Nasal Insufflation (TNI) [nasal canula]<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inspiratory airflow |  | 2 nights | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep apnea severity (AHI) |  | 2 nights | 
| Change in Ratio of apnea-to-hypopnea events |  | 2-nights | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, snoring, sleep apnea treatment, TNI, Trans nasal insufflation, Open CPAP