Resting Energy Expenditure in Patients With OHS Treated With Long-term NIV

NCT04474587 | Suspended

• 1 other identifier: 2020-01223
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare, in subjects with obesity-hypoventilation syndrome (OHS) treated by long-term non-invasive ventilation (NIV), resting energy expenditure (REE) in spontaneous breathing and under NIV. The hypothesise of this study is that REE will be lower under NIV than under spontaneous breathing.

Conditions

Obesity-hypoventilation Syndrome; Resting Energy Expenditure; Long-term Non-invasive Ventilation

Outcome Measures

Primary Outcomes (1)

• REE

  Resting energy expenditure (REE) and will be determined under spontaneous breathing and under NIV with an indirect calorimetry

  Each procedure (indirect calorimetry) will take 30 minutes

Study Arms (1)

OHS-NIV

Patients with obesity-hypoventilation syndrome (OHS) treated with non-invasive ventilation (NIV).

Other: Indirect calorimetry

Interventions

Indirect calorimetry OTHER

Measurements of REE by indirect calorimetry

OHS-NIV

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with obesity hypoventilation syndrome (OHS) trated with non-invasive ventilation (NIV).

You may qualify if:

• Fulfill all criteria of obesity hypoventilation syndrome.
• Under home NIV for at least 3 months.
• Are compliant to their treatment of NIV (defined as a daily median use \> 3:30 hours).
• Have a satisfactory response to NIV (defined by a daytime PaCO2 in a sitting position \< 6.5 kPa, and a mean nocturnal SpO2 \> 90%, with less than 20% of total recording time spent with an SpO2 \< 90%).
• Are in a stable clinical condition (i.e. no episode of acute cardiac and/or respiratory failure leading to a hospitalization within the preceding 3 months).
• Are over 18 years of age.
• Are able to provide informed consent.
• Agree to participate in the study.

You may not qualify if:

• Presents any respiratory disorder other than OHS.
• Has been under NIV less than 3 months.
• Is noncompliant (defined above) and/or intolerant to NIV.
• NIV not reaching the above-mentioned physiological targets (defined by a daytime PaCO2 in a sitting position \< 6.5 kPa, and a mean nocturnal SpO2 \> 90%, with less than 20% of total recording time spent with an SpO2 \< 90%).
• Had a recent episode of cardiac and/or respiratory failure leading to a hospitalization within the preceding 3 months.
• Is under 18 years of age.
• Presents a situation interfering with understanding of the protocol and ability to provide informed written consent (language barrier, cognitive disorder, psychiatric disturbance).
• Refuses to participate in the study.
• Is under nocturnal oxygen supplementation on NIV.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospital

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Interventions

Calorimetry, Indirect

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calorimetry; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jean-Paul Janssens

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 17, 2020
• Study Start: September 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-10

Locations

CH (1)