Pathogenesis and Outcomes of Sleep Disordered Breathing in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01764165

Last Updated: 2016-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-10-31

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.

Detailed Description

Chronic obstructive pulmonary disease (COPD) is associated with significant morbidity including substantial daytime fatigue exertional intolerance and ventilatory impairment, which hits a nadir in the morning. Nocturnal disturbances in sleep and breathing are common in COPD, although the impact of these disturbances on COPD morbidity remains largely unknown. The hypothesis is that COPD induces specific sleep and breathing disturbances that remain a substantial source of morbidity in this disorder.

Current therapy for treating nocturnal disturbances in sleep and breathing in COPD including nocturnal oxygen has failed to improve morning fatigue and pulmonary function. This study promises to significantly alter our approach to the diagnosis and management of sleep disordered breathing in COPD.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

oxygen

nocturnal oxygen of 2 L/min

Group Type: ACTIVE_COMPARATOR

Oxygen

Intervention Type: OTHER

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

High Flow of room air

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

Group Type: EXPERIMENTAL

High flow of room air

Intervention Type: OTHER

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

Interventions

Oxygen

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

Intervention Type: OTHER

High flow of room air

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

Intervention Type: OTHER

Other Intervention Names

supplemental oxygen; nocturnal oxygen; TNI: Transnasal insufflation; Open CPAP; Optiflow

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Hartmut Schneider

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hartmut Schneider, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19129290 (View on PubMed)

Other Identifiers

NA_00040333

Identifier Type: OTHER

Identifier Source: secondary_id

R01HL105546-01

Identifier Type: NIH

Identifier Source: org_study_id

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