Nocturnal Oxygen Needs and Central Sleep Apnea in Patients With Chronic Heart Failure.

NCT03254212 | Unknown Phase 4

• 1 other identifier: OXY-GRA-17027-LOFTHF-SH
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The aims of this study are to 1) determine the optimal levels of O2 flow which prevent nocturnal O2 desaturation while minimizing periods of hyperoxia during the course of nocturnal oxygen therapy (NOXT) in heart failure patients with reduced ejection fraction (HFrEF) patients with CSA/CSR; 2) document whether within-patient EO2F values change over time during NOXT, and identify factors which predict changes in EO2F; and 3) examine how well a conventional stepwise titration procedure compares to a breath by breath titration using an automated O2 titration system in terms of targeted flow rate and night time oxygenation (oxygen desaturation index, time spent at specific SpO2 targets).

Conditions

Chronic Heart Failure; Central Sleep Apnea

Keywords

Heart failure; Central sleep apnea; oxygen therapy

Outcome Measures

Primary Outcomes (2)

• Changes in optimal levels of O2 flow ( EO2F) which prevent nocturnal O2 desaturation

  changes in the lowest flow rate (1L/min to 4L/min) that maintained oxyhemoglobin saturation to \> 90% (Tsat90%) for ≥ 98% of the estimated sleep period and reduced the oxygen desaturation index (ODI3P) to \< 5/hour

  Three months ( titration completed 3 times during the study period)

• Accuracy of automated oxygen titration

  examine how well a conventional stepwise titration procedure compares to a breath by breath titration using an automated O2 titration system in terms of targeted flow rate and night time oxygenation (oxygen desaturation index, time spent at specific SpO2 targets)

  Three months (new titration sessions completed 3 times during the study period)

Study Arms (1)

Oxygen therapy

EXPERIMENTAL

Fixed nightime oxygen therapy throughout the protocol duration

Device: Titration of nocturnal oxygen needs to prevent desaturations

Interventions

Titration of nocturnal oxygen needs to prevent desaturations DEVICE

Oximetry recordings will be performed using a Pulse Oximeter. Two O2 titration sessions will be conducted at home in random order one week apart. One will consist of a stepwise night-to-night increase in O2 flow for up to 4 nights with supplemental O2, each at flow rates of 1L/min, 2L/min, 3L/min and 4L/min, respectively. During the other titration session, an automatic O2 delivery system will be used for 4 consecutive nights with O2 flow allowed to vary from 0 to 4 L/min with a 95 ± 2% SpO2 target. At the end of the titration periods, oxygen concentrators will be set at the lowest flow rate (1L/min to 4L/min) that maintained oxyhemoglobin saturation to \> 90% (Tsat90%) for ≥ 98% of the estimated sleep period and reduced the oxygen desaturation index 3% (ODI3) to \< 5/hour according to conventional O2 titration. If these targets are not reached, the lowest flow rate will be selected that minimizes the ODI3. These procedures will be repeated at week 5 and 11.

Oxygen therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with heart failure and reduced ejection fraction (LVEF \< 45%) due to ischemic or hypertensive heart disease
• moderate to severe central sleep apnea/cheyne stokes respiration.
• treatment should be stable for the last 30 days preceding entry into the study.

You may not qualify if:

• O2 /CPAP therapy,
• active smoking,
• primary valvular heart disease,
• nasal obstruction,
• BMI ≥ 32 Kg/m2,
• cardiac surgery/transient ischemic attack/stroke/resynchronization therapy within 3 months,
• nocturnal hypoventilation,
• receiving opiates or methadone medication.

Sponsors & Collaborators

• Laval University: lead
• Oxynov: collaborator
• Philips Respironics: collaborator

Study Sites (2)

Frédéric Sériès

Québec, Qiebec, G1V 4G5, Canada

RECRUITING

John Kimoff

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Central; Heart Failure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Frederic Series, MD

CONTACT

418 656 8711; frederic.series@med.ulaval.ca

Hugo Tremblay, MSc

CONTACT

418 656 8711; hugo.tremblay@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director IUCPQ Sleep laboratory

Model Details: Fixed nightime oxygen therapy throughout the study duration with oxygen flow determined according to the results of the home oxygen titration procedure.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 18, 2017
• Study Start: April 15, 2018
• Primary Completion: October 30, 2022
• Study Completion: December 31, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)