Recruiting

Observational Study

Sponsor:

Laval University

Code:

NCT03254212

Conditions

Chronic Heart Failure

Central Sleep Apnea

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Titration of nocturnal oxygen needs to prevent desaturations

Study Details

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

Study ID

NCT03254212

Start date

Apr 15, 2018

Status verified date

Apr, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Oct 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

14 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oxygen therapy

Fixed nightime oxygen therapy throughout the protocol duration

Interventions

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 measure

  • 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) ]
  • Accuracy of automated oxygen titration [ Time Frame: Three months (new titration sessions completed 3 times during the study period) ]

Central Contacts and Locations

Central contacts

Frederic Series, MD

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

Hugo Tremblay, MSc

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

Locations

Frédéric Sériès

Recruiting

Quebec city, Qiebec, Canada, G1V 4G5

Contacts

Frédéric Sériès, MD

418 656 4747frederic.series@med.ulaval.ca

Frédéric Sériès, MD

418 656 4747ftrederic.series@med.ulaval.ca

John Kimoff

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contacts

John Kimoff, MD

514-934-1934john.kimoff@mcgill.ca

More Information

Sponsor

Laval University

Last update posted

Apr 8, 2022

Last verified

Apr, 2022

Keywords

  • Heart failure
  • Central sleep apnea
  • oxygen therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2022-04-08.