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PSG Versus Oxim-capnography to Setup Home NIV

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02444806
Enrollment
14
Registered
2015-05-15
Start date
2015-01-31
Completion date
2016-03-31
Last updated
2016-07-12

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

Conditions

COPD, OSA

Keywords

Sleep disordered breathing, Domiciliary NIV

Brief summary

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

Detailed description

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.

Interventions

Full sleep and respiratory monitoring with EEG

OTHEROximetry-capnography

Limited monitoring with nurse observation and continuous oximetry-capnography overnight for NIV titration.

Sponsors

University Hospital, Rouen
CollaboratorOTHER
Guy's and St Thomas' NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PaCO2 (Arterial blood gas analysis)3 monthsArterial blood gas analysis

Secondary

MeasureTime frameDescription
Spirometry (FEV1, FVC)3 monthsFEV1, FVC
Subjective sleep comfort (VAS)3 monthsVAS
Health related quality of life (CAT, SRI)3 monthsCAT, SRI
Respiratory mechanics (to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara)Day 1Invasive respiratory mechanics performed on discharge NIV settings to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara
NIV compliance (machine recorded)3 monthsNIV machine recorded compliance
Objective sleep comfort (Actigraphy)3 monthsActigraphy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026