NCT01764165

Brief Summary

This research is being conducted to examine the effects of nasal insufflation of warm and humidified air through a small nasal cannula on sleep, breathing pulmonary function, and daytime exercise capability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

July 16, 2010

Completed
2 years until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

4.2 years

First QC Date

July 16, 2010

Last Update Submit

October 4, 2016

Conditions

COPD

Keywords

COPDSleepSupplemental oxygenBreathing mechanicsnasal insufflation

Outcome Measures

Primary Outcomes (1)

  • The evening to morning differences in expiratory airflow obstruction (FEV1/FVC)

    Lung function declines over the course of the night. We hypothesize that delivering warm and humidified air at a rate of 20 L/min over the entire night improves morning FEV1 compared to oxygen.

    4 years

Secondary Outcomes (2)

  • The percent rate of inspiratory flow limitation.

    4 Years

  • Effect of High flow nasal insufflation of air on exercise capacity (6 minute walk test).

    One Year

Other Outcomes (2)

  • Sleep efficiency

    4 years

  • Episodes of dynamic hyperinflation

    4 years

Study Arms (2)

oxygen

ACTIVE COMPARATOR

nocturnal oxygen of 2 L/min

Other: Oxygen

High Flow of room air

EXPERIMENTAL

Warm and humidified air at a rate of 20 L/min through a small nasal cannula (similar to oxygen cannula)

Other: High flow of room air

Interventions

OxygenOTHER

oxygen at a rate of 2 L/min will be delivered through a small nasal cannula throughout sleep.

Also known as: supplemental oxygen, nocturnal oxygen
oxygen
High flow of room airOTHER

Warm and humidified air at rates of 20 L/min will be delivered through a small nasal cannula throughout sleep

Also known as: TNI: Transnasal insufflation, Open CPAP, Optiflow
High Flow of room air

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consenting adults over the age of 21
  • BMI \< 40 kg/m2

You may not qualify if:

  • Diagnosed with sleep apnea (apnea and hypopneas of \>10 events/hr).
  • A sleep efficiency of \<30%, or a prior diagnosis of disorders that impair sleep architecture.
  • Unstable cardiovascular disease (decompensated heart failure, myocardial infarction within the past 3 months, revascularization procedure within the past 3 months, unstable arrhythmias, uncontrolled hypertension (BP \> 190/110)).
  • Severe renal insufficiency requiring dialysis.
  • Liver cirrhosis.
  • A recent acute illness in a 6 weeks period prior to the sleep studies.
  • We will exclude subjects with severe daytime hypoxemia (Oxyhemoglobin saturation (SaO2) \<80% or partial pressure of oxygen (PaO2) \<55 mmHg at rest).
  • Chronic use of sedatives or respiratory depressants that would affect sleep quality (e.g., benzodiazepines or other hypnotics or narcotics).
  • Pregnancy.
  • Tracheostomy or other significant oropharyngeal or nasopharyngeal surgery, in the last 6 months.
  • Narcolepsy and other neurological disorders such as Parkinson's Disease.
  • Severe hepatic insufficiency.
  • Bleeding disorders or Coumadin use.
  • Allergy to lidocaine or benzocaine.
  • Language/dementia/psychiatric issues - the participant must be able to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • Schneider H, Krishnan V, Pichard LE, Patil SP, Smith PL, Schwartz AR. Inspiratory duty cycle responses to flow limitation predict nocturnal hypoventilation. Eur Respir J. 2009 May;33(5):1068-76. doi: 10.1183/09031936.00063008. Epub 2009 Jan 7.

    PMID: 19129290BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Hartmut Schneider, M.D., Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 16, 2010

First Posted

January 9, 2013

Study Start

August 1, 2012

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 5, 2016

Record last verified: 2016-10

Locations

US(1)