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

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ClinicalTrials.gov Identifier: NCT03254212
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : February 21, 2020
Sponsor:
Collaborators:
Oxynov
Philips Respironics
Information provided by (Responsible Party):
Frédéric Sériès, Laval University

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).

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Central Sleep Apnea Device: Titration of nocturnal oxygen needs to prevent desaturations Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Fixed nightime oxygen therapy throughout the study duration with oxygen flow determined according to the results of the home oxygen titration procedure.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Nocturnal Oxygen Needs in the Treatment of Central Sleep Apnea in Patients With Chronic Heart Failure.
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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)



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254212


Contacts
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Contact: Frederic Series, MD 418 656 8711 ext 5513 frederic.series@med.ulaval.ca
Contact: Hugo Tremblay, MSc 418 656 8711 ext 3797 hugo.tremblay@criucpq.ulaval.ca

Locations
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Canada, Qiebec
Frédéric Sériès Recruiting
Quebec city, Qiebec, Canada, G1V 4G5
Contact: Frédéric Sériès, MD    418 656 4747    frederic.series@med.ulaval.ca   
Contact: Frédéric Sériès, MD    418 656 4747    ftrederic.series@med.ulaval.ca   
Canada, Quebec
John Kimoff Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: John Kimoff, MD    514-934-1934    john.kimoff@mcgill.ca   
Sponsors and Collaborators
Laval University
Oxynov
Philips Respironics
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Responsible Party: Frédéric Sériès, Director IUCPQ Sleep laboratory, Laval University
ClinicalTrials.gov Identifier: NCT03254212    
Other Study ID Numbers: OXY-GRA-17027-LOFTHF-SH
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frédéric Sériès, Laval University:
Heart failure
Central sleep apnea
oxygen therapy
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Central
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases