NCT00832026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
Last Updated

May 12, 2023

Status Verified

September 1, 2018

Enrollment Period

1.7 years

First QC Date

January 27, 2009

Last Update Submit

May 10, 2023

Conditions

Obstructive Sleep Apnea

Keywords

sleep apneasnoringsleep apnea treatmentTNITrans nasal insufflationOpen CPAP

Outcome Measures

Primary Outcomes (1)

  • Change in inspiratory airflow

    2 nights

Secondary Outcomes (2)

  • Change in sleep apnea severity (AHI)

    2 nights

  • Change in Ratio of apnea-to-hypopnea events

    2-nights

Study Arms (1)

Sleep apnea

Patients with diagnosed obstructive sleep apnea

Device: Trans Nasal Insufflation (TNI) [nasal canula]

Interventions

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.

Sleep apnea

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with obstructive sleep apnea are eligbile to participate in this study.

You may qualify if:

  • Consenting adults over the age of 21
  • Diagnosed obstructive sleep apnea

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Related 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.

    PMID: 17363769RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea SyndromesSnoring

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 29, 2009

Study Start

July 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

May 12, 2023

Record last verified: 2018-09

Locations

US(1)