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Completed

NCT Number: NCT04327336

Randomized Controlled Trial Between Auto-titration and Manual Titration of Non-invasive Ventilation in Obesity Hypoventilation Syndrome

Primary Objectives: To evaluate the effectiveness in the obesity hypoventilation syndrome (OHS) treatment with non-invasive ventilation (NIV) set manually by polysomnography compared to the same treatment with a respirator with automatic NIV adjustment, analyzing as primary variable PaCO2 and as operational variables dropout rate for medical reasons and mortality. Secondary objectives: cost-effectiveness, clinical and functional improvement in wakefulness and during sleep, quality of life, blood pressure monitoring for 24 hours, incidence and evolution of cardiovascular events and use of health resources. Other objectives: 1) effectiveness of treatments in the following subgroups of patients: gender, age, socioeconomic status, severity of sleep apnea, VNI compliance, quality of life and comorbidities; 2) To evaluate the profile of patients with poor adherence to NIV based on clinical severity, gender, age and socioeconomic status in the whole sample and in both intervention groups.

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Key information

Conditions

Chronic Hypercapnic Respiratory Failure Apnea Body Weight Dyssomnias Hypoventilation Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Hypoventilation Syndrome Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juan F. Masa

Cáceres, 10003, Spain

About this study

Method: Prospective, blind researchers, randomized, controlled non-inferiority and cost-effectiveness relationship, with two parallel open groups. 200 OHS patients will be divided into two groups by simple randomization 1:1 and followed for one year. The premise of non-inferiority is -2 at the lower limit of the confidence interval 95% for the change in PCO2 between the arms being assessed by analysis of covariance, adjusted for 2-sided, age, sex, body mass index in intention-to-treat and per-protocol analysis. The cost-effectiveness will be performed by Bayesian techniques with sensitivity analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obesity Hypoventilation Syndrome defined by obesity (IMC≥30) and Hypercapnic respiratory failure (PCO 2> 45 mm Hg) in stable phase (PH≥7.35 without clinical signs of worsening in at least one previous month).
  • Age between 18-80 years.
  • Absence of other diseases causing hypercapnia as moderate or severe chronic obstructive pulmonary disease (FEV1> 70% predicted if FEV1 / FVC <70), neuromuscular, thoracic wall or metabolic disease; d) Absence of narcolepsy or restless legs syndrome.
  • Overcome correctly a 30 minutes test of treatment with VNI in wakefulness.

Exclusion criteria

  • Psychophysical disability for questionnaires.
  • Patients who cannot be evaluated by quality of life questionnaires because they present debilitating chronic disease.
  • Chronic nasal obstruction that prevents the use of NIV.
  • Pregnancy.
  • No informed consent obtained.

Treatment and study plan

Manual Non invasive ventilation titration

Device

Manual Group: during a complete polysomnography, adding transcutaneous capnography and the basic ventilators curves, the ventilators setting will be adjusted in order to correct respiratory events and patient-ventilator asyncrony. A 10 hours face-to-face investigator training meeting is programmed before opening the inclusion period.

Automatic Non invasive ventilation titration

Device

Automatic Group: the A40 ventilator in the automatic AVAPS mode will be adjusted in order to achieve 8-10 ml/kg of ideal weight.

Primary outcomes

  1. Change in PaCO2 between arms

    Time frame: 1 year

    Arterial blood gases while room air breathing expressed in mmHg

Secondary outcomes

  1. Cost-effectiveness analysis by primary outcome

    Time frame: 1 year

    Cost-effectiveness analysis based on the primary outcome in mmHg Differences in within trial costs will be related with the differences in effectiveness (primary outcome) between arms using a probabilistic Bayesian approach to calculate the cost-effectiveness plane.

  2. Cost-effectiveness analysis by QALY

    Time frame: 1 year

    Cost-effectiveness analysis based on the quality adjusted life year (QALY) Differences in within trial costs will be related with the differences in effectiveness (QALY) between arms using a probabilistic Bayesian approach to calculate the cost-effectiveness plane.

  3. Change in subjective daytime sleepiness

    Time frame: 1 year

    Sleepiness evaluated by Epworth sleepiness scale, range from 0 to 24, being 0 the best result and 24 the worst.

  4. Change in Quality of life measured by Functional Sleep Outcomes of Sleep Questionnaire (FOSQ)

    Time frame: 1 year

    Quality of life measured by Functional Sleep Outcomes of Sleep Questionnaire (FOSQ), range from 0 to 120, being 0 the worst result and 120 the best result .

  5. Change in Quality of life measured by visual analogical wellbeing scale (VAWS)

    Time frame: 1 year

    Quality of life measured by visual analogical well-being scale (VAWS), range from 0 to 100, being 0 the worst result and 120 the best result .

  6. Change in Quality of life measured by Euroqol 5D.

    Time frame: 1 year

    Quality of life measured by Euroqol 5D, range from 0 to 1, being 0 the worst result and 1 the best result .

  7. Change in Quality of life measured by Short Form-36 (SF36), Mental component

    Time frame: 1 year

    Quality of life measured by Short Form-36 (SF36) Mental component,range from 0 to 100, being 0 the worst result and 100 the best result.

  8. Change in Quality of life measured by Short Form-36 (SF36), Physical component

    Time frame: 1 year

    Quality of life measured by Short Form-36 (SF36) Physical component,range from 0 to 100, being 0 the worst result and 100 the best result.

  9. Change in Bicarbonate arterial blood concentration

    Time frame: 1 year

    Arterial blood gases while breathing room air expressed in mmol/L

  10. Change in PaO2

    Time frame: 1 year

    Arterial blood gases while breathing room air expressed PaO2 in mmHg

  11. Change in pH

    Time frame: 1 year

    Arterial blood gases while breathing room air

  12. Change in polysomnographic Sleep periods

    Time frame: 1 year

    Standard polysomnography. time of sleep periods (Stage 1,2,3,4 and REM) in minutes.

  13. Change in Arousal Index

    Time frame: 1 year

    Standard polysomnography, number of arousals per sleep hour

  14. Change in Apnea-Hypopnea index

    Time frame: 1 year

    Standard polysomnography, number of apneas and hypoapneas per sleep hour

  15. Change in Oxygen desaturation index

    Time frame: 1 year

    Standard polysomnography, number of 3% or more Oxygen desaturations per sleep hour

  16. Change in Sleep time with Oxygen saturation below 90%

    Time frame: 1 year

    Standard polysomnography, percentage of sleep time with oxygen saturation below 90%

  17. Change in polysomnographic parameters: Total Sleep time (TTS)

    Time frame: 1 year

    Standard polysomnography, time in minutes

  18. Change in the blood pressure monitoring

    Time frame: at baseline and after a year

    The blood pressure will be monitored during 24 hours with a Blood Pressure Monitoring device before (baseline) and after intervention (1 year) in both arms measured in mmHg. Change in the mean blood pressure will be compared between arms

  19. Incidental cardiovascular events

    Time frame: 1 year

    New hypertension diagnosis or anti-hypertensive treatment, atrial fibrillation, hospitalization for nonfatal myocardial infarction or instable angina, nonfatal stroke or transient ischemic attack or for heart failure episode, and cardiovascular death. Data obtained from official electronic health care databases

  20. Health care resources utilization: Hospital admission

    Time frame: 1 year

    Hospital admission measured in number of events

  21. Health care resources utilization: Hospital duration

    Time frame: 1 year

    Hospital duration measured in days of hospitalization

  22. Health care resources utilization: ICU admission

    Time frame: 1 year

    ICU admission measured in numbers of events

  23. Health care resources utilization: ICU duration

    Time frame: 1 year

    ICU duration measured in days of UCI admissions

  24. Health care resources utilization: emergency visits

    Time frame: 1 year

    Emergency visits measured in number of events

  25. Health care resources utilization: primary care visits

    Time frame: 1 year

    Primary care visits measured in number of events

  26. Health care resources utilization: specialist visits

    Time frame: 1 year

    Specialist visits measured in number of events

  27. Incidence of new adverse event

    Time frame: 1 year

    Number of adverse events based in CTCAE v4.0

  28. Side effects

    Time frame: 1 year

    Incidence or side effects of NIV in follow-up visits: excessive noise, headache, claustrophobia, difficulty in sleep conciliation or maintenance, expiration discomfort.

Other outcomes

  1. Adherent vs. non-adherent to noninvasive ventilation therapy subgroups

    Time frame: 1 year

    Efficacy between arms measuring Epworth sleepiness scale (from 0 to 24 points) comparing adherent vs. non-adherent to non-invasive ventilation therapy subgroups (higher and lower of 4 hours per day)

  2. Sleep apnea severity subgroup

    Time frame: 1 year

    Efficacy between arms measuring Epworth sleepiness scale (from 0 to 24 points) comparing sleep apnea severity subgroups measured by apnea and hypopnea index at baseline (higher and lower of the median)

  3. Hypercapnia severity subgroup

    Time frame: 1 year

    Efficacy between arms measuring Epworth sleepiness scale (from 0 to 24 points) comparing hypercapnia severity subgroups measured by PaCO2 (mmHg) at baseline (higher and lower of the median)

  4. Systemic hypertension subgroup

    Time frame: 1 year

    Efficacy between arms measuring Epworth sleepiness scale (from 0 to 24 points) comparing the presence of hypertension diagnosis subgroups at baseline

  5. Hypercapnia resolution subgroup

    Time frame: 1 year

    Efficacy between arms measuring Epworth sleepiness scale (from 0 to 24 points) comparing the resolution of hypercapnia measured by PaCO2 (mmHg) at the end of the follow-up (higher and lower of 45 mmHg)

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Registry information

Official study title

Effectiveness of Noninvasive Ventilation Adjusted Automatically in the Obesity Hypoventilation Syndrome

Acronym: TITRATION

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2020
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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