Trans Nasal Insuflation 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 : Unknown
Verified January 2009 by Johns Hopkins University.
Recruitment status was:  Active, not recruiting
First Posted : January 29, 2009
Last Update Posted : January 29, 2009
Information provided by:
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 Insuflation (TNI) [nasal canula]

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Trans Nasal Insuflation for the Treatment of Snoring and Obstructive Sleep Apnea
Study Start Date : July 2004

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 Insuflation (TNI) [nasal canula]

Trans Nasal Insuflation, 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

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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 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

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University

Publications of Results:
Responsible Party: Hartmut Schneider, Johns Hopkins University Identifier: NCT00832026     History of Changes
Other Study ID Numbers: NA_00019483
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009

Keywords provided by Johns Hopkins University:
sleep apnea
sleep apnea treatment
Trans nasal insuflation

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Nervous System Diseases
Respiratory Sounds