Treatment of Central Sleep Apnoea in Patients With Heart Failure With Nasal High Flow Therapy (nHFT)

NCT03085641 | Terminated DMC

• 1 other identifier: 201700147
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether nHFT is an effective treatment for patients with Chronic Heart Failure (CHF) and central sleep apnea (CSA). This study is a prospective one armed uncontrolled intervention pilot study investigating 4 weeks of nHFT at home in 10 patients with CHF and CSA.

Conditions

Central Sleep Apnea; Cheyne-Stokes Respiration

Keywords

High flow oxygen therapy

Outcome Measures

Primary Outcomes (1)

• Reduction of apnea/hypopnea index

  the change/reduction in AHI after 4 weeks of treatment with nHFT.

  Baseline, 4 weeks

Secondary Outcomes (10)

• Improvement physical condition

  Baseline, 4 weeks

• Work of breathing

  Baseline titration night

• Drive to breath

  Baseline titration night, 4 weeks

• Sleep latency

  Baseline, 4 weeks

• Cardiac functioning

  Baseline, 4 weeks

Study Arms (1)

Nasal high flow oxygen therapy

EXPERIMENTAL

The patient is hospitalized for one night. Initially patients will start with a flow rate of 10 L/min and when they are asleep during the night 90-minute periods of the following settings will be performed: * Moderate flow rate: 20 L/min without additional oxygen (with room air, which means a fractional inspired oxygen (FiO2) of 21%) * High flow rate: 40-50 L/min without additional oxygen * Moderate flow rate: 20 L/min with FiO2 of 28% (comparable to the 2 L/min additional oxygen through a nasal cannula) * High flow rate: 40-50 L/min with FiO2 of 28%

Device: Nasal high flow oxygen therapy

Interventions

Nasal high flow oxygen therapy DEVICE

nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively

Nasal high flow oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe CSA/CSR (AHI\>15), in which CSA is defined when at least 50% of the apnoeas are central apnoeas
• Heart failure with reduced ejection fraction, defined as a LVEF \< 45% of predicted

You may not qualify if:

• Other diseases affecting respiration during sleep (COPD GOLD 3 or 4, neuromuscular disorders, thorax cage deformities)

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

Department of Pulmonary diseases

Groningen, Netherlands

Location

MeSH Terms

Conditions

Sleep Apnea, Central; Cheyne-Stokes Respiration

Condition Hierarchy (Ancestors)

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

Study Officials

• Marieke Duiverman

  University Medical Center Groningen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pneumologist

Model Details: prospective one armed uncontrolled intervention pilot study

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 21, 2017
• Study Start: June 15, 2017
• Primary Completion: October 18, 2018
• Study Completion: October 18, 2018
• Last Updated: December 17, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)