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Comparison of two methods to treat obesity hypoventilation syndrome: Noninvasive ventilation (NIV) and continuous positive airway pressure (CPAP)

Switch of noninvasive ventilation (NIV) to continuous positive airway pressure (CPAP) in patients with obesity hypoventilation syndrome: a proof of concept study in real life conditions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13981084
Enrollment
15
Registered
2017-02-27
Start date
2015-09-01
Completion date
Unknown
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity hypoventilation syndrome Respiratory Obesity hypoventilation syndrome

Interventions

Participants undergoing treatment for obesity hypoventilation syndrome (OHS) undergo a systematic pre-established switch from using non invasive ventilation (NIV) to using a continuous positive airway

Sponsors

Alain Palot
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 years old or older 2. Suffering from obesity hypoventilation syndrome (OHS) defined as an association of obesity (BMI = 30 kg/m²) and daytime hypercapnia (paCO2 > 45 mm Hg)) 3. Patients who had been undergoing noninvasive ventilation (NIV) for more than 2 months 4. Clinically stable for at least 4 weeks before enrollment in the study (no hospitalization or emergency admission)

Exclusion criteria

Exclusion criteria: 1. Hypercapnia secondary to other causes (obstructive pulmonary diseases (FEV1/FVC < 70), interstitial lung diseases, neuromuscular or chest wall diseases, severe hypothyroidism or congenital central hypoventilation syndrome) 2. Patients unable to give informed consent to data collection and analysis

Design outcomes

Primary

MeasureTime frame
Severity of sleep apnea is measured using the Apnea-Hypopnea index at baseline and 1 month after starting of CPAP.

Secondary

MeasureTime frame
1. Oxygen saturation and transcutaneous measurement of pCO2 are measured using daytime arterial blood gas and nocturnal alveolar gas exchange at baseline and 1 month after starting of CPAP 2. Sleepiness is measured using the Epworth Sleepiness Scale (EPS) at baseline and 1 month after starting of CPAP 3. Quality of sleep is measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline and 1 month after starting of CPAP 4. Quality of life is measured using Severe Respiratory Insufficiency questionnaire (SRI) at baseline and 1 month after starting of CPAP

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026