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Trans Nasal Insufflation for the Treatment of Snoring (TNI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00832026
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : September 18, 2018
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Device: Trans Nasal Insufflation (TNI) [nasal canula]

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea Snoring

Group/Cohort Intervention/treatment
Sleep apnea
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.

Primary Outcome Measures :
  1. Change in inspiratory airflow [ Time Frame: 2 nights ]

Secondary Outcome Measures :
  1. Change in sleep apnea severity (AHI) [ Time Frame: 2 nights ]
  2. Change in Ratio of apnea-to-hypopnea events [ Time Frame: 2-nights ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with obstructive sleep apnea are eligbile to participate in this study.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00832026

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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Publications of Results:
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Responsible Party: Johns Hopkins University Identifier: NCT00832026    
Other Study ID Numbers: NA_00019483
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Keywords provided by Johns Hopkins University:
sleep apnea
sleep apnea treatment
Trans nasal insufflation
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds