Nocturnal Oxygen Needs and Central Sleep Apnea in Patients With Chronic Heart Failure. (HO2F)

April 6, 2022 updated by: Frédéric Sériès, Laval University

Evaluation of Nocturnal Oxygen Needs in the Treatment of Central Sleep Apnea in Patients With Chronic Heart Failure.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sleep-related breathing disorders (obstructive and central) are highly prevalent in Heart failure (HF) patients and are associated with an increase in morbidity and mortality. Nocturnal oxygen therapy (NOT) reduces the frequency of central breathing events by 75 % and prevents nocturnal desaturation in patients with HF. Considering that the amount of nocturnal desaturation is a better predictor of mortality than the apnea+hypopnea index (AHI) in this population, one should expect NOT to have a positive impact on survival in these patients. In the four randomized clinical trials where the effects of O2 on left ventricular function was assessed, 2 reported a significant increase in LVEF after 3 months of NOT. NOT was also found to positively impact on other important predictive factors of mortality such as sympathetic activity and VO2 max. These mitigated results could be accounted by the fact that a fixed O2 flow was empirically used (2 to 4 L/min) in the majority of studies. This may impede the beneficial effects of NOT for two reasons. First, in patients with HF, oxygen is associated with a dose-related detrimental hemodynamic effects (i.e. increase in vascular resistance and reduction in cardiac output and stroke volume). Therefore, the lowest O2 flow that prevents nocturnal desaturation should be used to minimize the detrimental effects of hyperoxia. On the other hand, there are evidences that the frequency and/or severity of sleep-disordered breathing may change overtime in CHF patients leading to insufficient correction of nocturnal desaturation during the course of NOT. Therefore, NOT should be preceded by an oxygen titration procedure to determine the lowest O2 flow that prevents nocturnal desaturation. This can be done with a stepwise night-to-night increase in O2 flow until correction of nocturnal desaturation. However, another approach would be to prevent event-by-event desaturations and to prevent hyperoxia during periods of normal sleep and wakefulness. On the other hand, the stability in O2 needs overtime in these patients is unkown. The aims of this study are 1) to document if the level of O2 flow preventing nocturnal desaturation changes during the course of NOT in CHF patients with CSA/CSR and 2) to examine the ability of automated O2 titration (FreeO2, Oxynov, Quebec, Canada) to determine O2 needs in HF patients with CSA/CSR when compared to the gold standard titration procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Oxygen therapy
Fixed nightime oxygen therapy throughout the protocol duration
Device: Titration of nocturnal oxygen needs to prevent desaturations
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in optimal levels of O2 flow ( EO2F) which prevent nocturnal O2 desaturation
Time Frame: Three months ( titration completed 3 times during the study period)
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
Time Frame: Three months (new titration sessions completed 3 times during the study period)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Philips Respironics
Oxynov

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OXY-GRA-17027-LOFTHF-SH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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