Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2016-10-31
2017-08-31
Brief Summary
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Detailed Description
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This study will be investigating whether the iO2Ts can reduce intermittent hypoxia during sleep compared to usual fixed flow oxygen in patients on LTOT. Nineteen patients will be recruited to undergo two sleep studies each on two different nights; one on their usual LTOT flow rate and one of the iO2Ts. During both sleep studies, all participants will have full polysomnography, oxygen and transcutaneous carbon dioxide monitoring. The primary outcome will the percentage of time spent with SpO2 \< 90% during sleep.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Sleep study on usual long-term oxygen therapy flow rate
Participants will have a sleep study on their usual LTOT flow rate.
No interventions assigned to this group
Sleep study on the intelligent oxygen therapy system
Participants will have a sleep study on the intelligent oxygen therapy system. This system will supply variable flow oxygen to match a pre-set oxygen saturation target of 93% during sleep.
Intelligent oxygen therapy system (iO2Ts)
Interventions
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Intelligent oxygen therapy system (iO2Ts)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. A diagnosis of obstructive sleep apnoea
3. A diagnosis of a neuromuscular disease
4. Daytime partial pressure of carbon dioxide \> 8.0 kPa
5. Inability to consent for the study
6. Exacerbation of the underlying lung disease or chest infection in the previous 4 weeks
7. Pregnancy
8. Severe co-morbidities
9. Patients with a tracheostomy
10. Long-term oxygen therapy flow rate ≥ 4 litre per minute
11. Inability to understand the English language
18 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Anita K Simonds
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Royal Brompton and Harefield NHS Foundation Trust
London, , United Kingdom
Countries
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Related Links
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Completed PhD thesis of M Moghall including results of Intelligent Oxygen therapy during sleep study
Other Identifiers
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15IC2590
Identifier Type: -
Identifier Source: org_study_id