Clinical trial NCT02444806: PSG Versus Oxim-capnography to Setup Home NIV
Official title: The Clinical Effectiveness of PSG Versus Limited Respiratory Polygraphy During NIV Set up in COPD-OSA Overlap Syndrome: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
OSA
Keywords: Sleep disordered breathing
Domiciliary NIV
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University Hospital, Rouen
First posted: 2015-05-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PaCO2 (Arterial blood gas analysis)
timeFrame: 3 months
Secondary outcomes:
measure: Health related quality of life (CAT, SRI)
timeFrame: 3 months
measure: Spirometry (FEV1, FVC)
timeFrame: 3 months
measure: Subjective sleep comfort (VAS)
timeFrame: 3 months
measure: Objective sleep comfort (Actigraphy)
timeFrame: 3 months
measure: Respiratory mechanics (to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara)
timeFrame: Day 1
measure: NIV compliance (machine recorded)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Patout M, Arbane G, Cuvelier A, Muir JF, Hart N, Murphy PB. Polysomnography versus limited respiratory monitoring and nurse-led titration to optimise non-invasive ventilation set-up: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):83-86. doi: 10.1136/thoraxjnl-2017-211067. Epub 2018 Mar 30.