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Trans Nasal Insufflation for the Treatment of Snoring

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00832026
Acronym
TNI
Enrollment
11
Registered
2009-01-29
Start date
2004-07-31
Completion date
2006-03-31
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea, snoring, sleep apnea treatment, TNI, Trans nasal insufflation, Open CPAP

Brief 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.

Interventions

DEVICETrans 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.

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in inspiratory airflow2 nights

Secondary

MeasureTime frame
Change in sleep apnea severity (AHI)2 nights
Change in Ratio of apnea-to-hypopnea events2-nights

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026