Status:
COMPLETED
Remote Monitoring to Improve Low Adherence in Non-invasive Ventilation
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Hypercapnic Respiratory Failure
Sleep Disordered Breathing
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Patients are invited to participate in a trial to test a new way to optimise long-term use of non-invasive ventilation using remote monitoring. Breathing difficulties during sleep are frequently treat...
Detailed Description
Participant Selection Patients established on NIV for \>3months will be recruited in this trial. The sample size calculation of n=32 patients is based on previous in-house data (Ishak A et al, Respir...
Eligibility Criteria
Inclusion
- hypercapnic respiratory failure (PaCO2 \> 6kPa)
- low usage of home mechanical ventilation (NIV \< 4hours/night).
- body mass index (BMI) \>18.5kg/m2
- all genders
- age 18-90years.
Exclusion
- no hypercapnic respiratory failure (PaCO2\<6kPa)
- no sleep-disordered breathing (AHI\<5/hour)
- exclusively obstructive sleep apnoea
- isolated Rapid-Eye-Movement (REM) sleep associated OSA
- cachexia (BMI \<18.5 kg/m2)
- severe pulmonary hypertension
- valvular heart disease
- heart failure (New York Heart Association, NYHA III-IV)
- myocardial infarction and significant cardiac arrhythmias
- uncontrolled hypertension
- active psychiatric disease
- co-existing non-respiratory sleep disorder.
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04884165
Start Date
March 28 2022
End Date
June 12 2024
Last Update
June 18 2024
Active Locations (1)
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1
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH