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
1 other identifier
interventional
14
0 countries
N/A
Brief Summary
The study aims to compare 2 different strategies used to setup non-invasive ventilation in patients with OCPD-OSA overlap.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2015
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 12, 2015
CompletedFirst Posted
Study publicly available on registry
May 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJuly 12, 2016
July 1, 2016
10 months
May 12, 2015
July 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PaCO2 (Arterial blood gas analysis)
Arterial blood gas analysis
3 months
Secondary Outcomes (6)
Health related quality of life (CAT, SRI)
3 months
Spirometry (FEV1, FVC)
3 months
Subjective sleep comfort (VAS)
3 months
Objective sleep comfort (Actigraphy)
3 months
Respiratory mechanics (to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara)
Day 1
- +1 more secondary outcomes
Study Arms (2)
Full Polysomnography
ACTIVE COMPARATORPatients will have NIV settings established using overnight full polysomnography.
Oximetry-capnography
ACTIVE COMPARATORPatients will have NIV settings established using only Oximetry-capnography and subjective sleep comfort.
Interventions
Full sleep and respiratory monitoring with EEG
Limited monitoring with nurse observation and continuous oximetry-capnography overnight for NIV titration.
Eligibility Criteria
You may qualify if:
- COPD (as defined by GOLD criteria\[4\])
- OSA (ODI \> 7.5 events/hr, AHI \> 5events/hr)
- PaCO2 \> 6 kPa
- BMI \> 30 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29602814DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2015
First Posted
May 15, 2015
Study Start
January 1, 2015
Primary Completion
November 1, 2015
Study Completion
March 1, 2016
Last Updated
July 12, 2016
Record last verified: 2016-07