Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization (NCT00603096) | Clinical Trial Compass
UnknownNot Applicable
Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization
France45 participantsStarted 2006-06
Plain-language summary
The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.
Who can participate
Age range
20 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Patients with a respiratory decompensation the month preceding the study
* Patients not autonomous in the use of the NIV
* Pacemaker patients, constituting a contraindication to magnetic stimulation
* Sensitive subjects, in accordance with article L 1121-6 of the French Public Health Code
* Patients with long term by steroids or other anti-inflammatory drugs
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.