Obstructive Sleep Apnea Clinical Trial
— TNIOfficial title:
Trans Nasal Insufflation for the Treatment of Snoring and Obstructive Sleep Apnea
NCT number | NCT00832026 |
Other study ID # | NA_00019483 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2004 |
Est. completion date | March 2006 |
Verified date | September 2018 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
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
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 |
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