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Randomized cross-over trial of demand oxygen delivery system in nocturnal hypoxemia

Randomized cross-over trial of demand oxygen delivery system in HOT patients with nocturnal hypoxemia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052190042
Enrollment
20
Registered
2019-08-23
Start date
2019-10-04
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Chronic obstructive pulmonary disease, interstitial pneumonia COPD, IP

Interventions

Arm A: Auto-demand oxygen delivery during sleeping and then Continuous flow oxygen during sleeping Arm B: Continuous flow oxygen during sleeping and then Auto-demand oxygen delivery during sleeping

Sponsors

Nagano Tatsuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Home oxygen therapy 2. Chronic obstructive pulmonary disease or interstitial pneumonia 3. Ambulatory patients with portable device 4. Written informed consent 5. More than 20 years old

Exclusion criteria

Exclusion criteria: 1. Noninvasive positive pressure ventilation therapy 2. Continuous Positive Airway Pressure therapy 3. Symptomatic congestive heart failure, unstable angina, history of myocardial infarction within 1 year prior to registration, clinically severe arrhythmia (CLBBB, 2nd and 3rd degree AV block, Vf) 4. Hemoglobin < 9 g/dL 5. History of acute exacerbation of chronic obstructive pulmonary disease or interstitial pneumonia within 3 months 6. Pregnant women or women who may be pregnant or breastfeeding 7. A judgment by the attending physician that patient participation would be inappropriate

Design outcomes

Primary

MeasureTime frame
nocturnal mean SpO2

Secondary

MeasureTime frame
sensitivity rate (%), the number of times and time that SpO2 became 90% or more, the lowest value of SpO2, Average/High pulse rate, apnea index, Apnea hypopnea index sleeping time, comfortable Degree, reliability

Contacts

Public ContactTatsuya Nagano

Kobe University Hosipital

tnagano@med.kobe-u.ac.jp+81-78-382-5660

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026