Suspended

NIV-OHSInterest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS)

What is being tested

GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare

Device

Who is being recruted

Apnea+14

+ Hypoventilation

+ Nervous System Diseases

From 20 to 75 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: June 2006

See protocol details

Summary

Principal SponsorTyco Healthcare Group

Study ContactMaud Boucherie, CRA

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2006

Actual date on which the first participant was enrolled.

Initiation of NIV treatment implies technical adjustments (choice of mask and ventilator), but also patient education by the nurses and medical staff. The settings are generally adjusted during the daytime in awake patients. The appropriateness of these settings is generally not optimal during sleep as many respiratory events (hypopnoea, apnea, leaks, desynchronization, and glottic closure) may occur under NIV then reducing the effectiveness of treatment. These nocturnal abnormalities are routinely evaluated by measuring their consequences, i.e. oxygen desaturation and the level of PaCO2 after wake up. Some teams are now proposing to better characterize what happens when using NIV during sleep using polysomnography (PSG). The precise characterization of residual events under treatment may allow optimizing ventilator settings.

Official TitleInterest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS)

NCT00603096

Principal SponsorTyco Healthcare Group

Study ContactMaud Boucherie, CRA

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaHypoventilationNervous System DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesityObesity Hypoventilation SyndromeRespiration DisordersRespiratory InsufficiencyRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Apnea, ObstructiveSleep Disorders, IntrinsicDyssomniasOvernutritionOverweight

Criteria

4 inclusion criteria required to participate

Patient male or female, aged 20 to 75 years

Patient with a OHS in stable condition, with a BMI> 32 kg/m2 and a PaCO2> 6 kPa in diurnal spontaneous breathing without other cause of alveolar hypoventilation

Patient affiliated to a social security insurance

Having given its written informed consent to participate to the study

9 exclusion criteria prevent from participating

Patients with inherent chronic obstructive pulmonary disease (COPD) with FEV1 on Forced Vital Capacity (FVC) ratio less than 70%

Patients suffering from heart failure with periodic breathing

Associated Neurological Diseases, evolving rapidly, leading to a dependency in daily activities

Unbalanced Psychiatric Diseases

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

patients will benefit from a complete polysomnography under NIV

Group II

Active Comparator

settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires - CHU Grenoble

Grenoble, FranceOpen Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires - CHU Grenoble in Google Maps

SuspendedOne Study Center