Trans Nasal Insufflation for the Treatment of Snoring

Obstructive Sleep Apnea Clinical Trial

— TNI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832026
• Other study ID #: NA_00019483
• Status: Completed
• Start date: July 2004
• Est. completion date: March 2006

Study information

• Verified date: September 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Snoring

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1164/rccm.200609-1336OC. Epub 2007 Mar 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inspiratory airflow		2 nights
Secondary	Change in sleep apnea severity (AHI)		2 nights
Secondary	Change in Ratio of apnea-to-hypopnea events		2-nights