PSG Versus Oxim-capnography to Setup Home NIV

Study Overview
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Brief Summary
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The study aims to compare 2 different strategies used to setup non-invasive ventilation in patients with OCPD-OSA overlap.

Detailed Description
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With limited comparative data to support the different strategies, there is substantial variation across Europe and the United States in the methods used by clinicians to set up home non-invasive ventilation (NIV) for patients with chronic respiratory failure as a consequence of sleep disordered breathing. Indeed with few data to support the practice, many centres employ full montage polysomnography, which is not only a significant physical burden to the patient but also a financial burden to the healthcare provider in terms of the facilities required, staff training and equipment. The investigators propose to undertake a randomised controlled trial to compare the clinical effectiveness, in terms of the change in daytime arterial partial pressure of carbon dioxide (PaCO2) at 3 months, of limited respiratory polygraphy and full polysomnography to set up NIV in patients with COPD-OSA overlap. Secondary outcome measures at 3 months will include overnight control of gas exchange, subjective sleep quality, health related quality of life and ventilator adherence. COPD-OSA overlap are a patient group that have a rising prevalence with limited data currently available detailing NIV set up, which wholly supports the rationale of using this increasingly important group as a target population for this trial.

Official Title
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The Clinical Effectiveness of PSG Versus Limited Respiratory Polygraphy During NIV Set up in COPD-OSA Overlap Syndrome: A Randomised Controlled Trial

Conditions
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COPD, OSA

Intervention / Treatment
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* Other: Full polysomnography
* Other: Oximetry-capnography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD (as defined by GOLD criteria[4]) OSA (ODI > 7.5 events/hr, AHI > 5events/hr) PaCO2 > 6 kPa BMI > 30 kg/m2 Exclusion Criteria: Decompensated respiratory failure (pH < 7.35) Inability to tolerate NIV (< 4 hours usage at in hospital titration) Contraindication to NIV Pregnancy Aged <18 Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Full Polysomnography<br>Patients will have NIV settings established using overnight full polysomnography. | Other: Full polysomnography<br>* Full sleep and respiratory monitoring with EEG<br>* Other names: Polysomnography;|
| Active Comparator: Oximetry-capnography<br>Patients will have NIV settings established using only Oximetry-capnography and subjective sleep comfort. | Other: Oximetry-capnography<br>* Limited monitoring with nurse observation and continuous oximetry-capnography overnight for NIV titration.<br>* Other names: Limited respiratory monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaCO2 (Arterial blood gas analysis) | Arterial blood gas analysis | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life (CAT, SRI) | CAT, SRI | 3 months | 
| Spirometry (FEV1, FVC) | FEV1, FVC | 3 months | 
| Subjective sleep comfort (VAS) | VAS | 3 months | 
| Objective sleep comfort (Actigraphy) | Actigraphy | 3 months | 
| Respiratory mechanics (to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara) | Invasive respiratory mechanics performed on discharge NIV settings to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara | Day 1 | 
| NIV compliance (machine recorded) | NIV machine recorded compliance | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep disordered breathing, Domiciliary NIV