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Completed

NCT Number: NCT00832026

Trans Nasal Insufflation for the Treatment of Snoring

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trans Nasal Insufflation (TNI) [nasal canula]

Device

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 outcomes

  1. Change in inspiratory airflow

    Time frame: 2 nights

Secondary outcomes

  1. Change in sleep apnea severity (AHI)

    Time frame: 2 nights

  2. Change in Ratio of apnea-to-hypopnea events

    Time frame: 2-nights

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Acronym: TNI

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 29, 2009
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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