Intelligent Oxygen Therapy During Sleep

Study Overview
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Brief Summary
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Long-term oxygen therapy improves survival in patients with severe hypoxia. However, some patients despite this oxygen, experience episodes of low oxygen levels (intermittent hypoxia) especially during sleep which may be harmful. In order to overcome this, the investigators have designed an auto-titrating oxygen system (called intelligent oxygen therapy) which automatically adjusts oxygen flow rates to maintain oxygen levels in patients already on oxygen. This study will investigate whether the intelligent oxygen therapy system can prevent intermittent hypoxia during sleep in patients already on long-term oxygen.

Detailed Description
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Long-term oxygen therapy (LTOT) improves survival in patients with chronic obstructive pulmonary disease (COPD) and severe persistent hypoxia. LTOT is prescribed at a fixed-flow rate with the aim of maintaining a partial pressure of oxygen greater than or equal to 8 kilopascals (kPa). However, a number of studies have demonstrated that patients on home LTOT experience episodes of intermittent hypoxia during rest, activities and especially sleep. Simply increasing the oxygen flow rate at night can relieve this hypoxia but at the expense of hyperoxia with its detrimental effects of hypercapnia and respiratory acidosis. Therefore, a more targeted approach is needed to oxygen delivery. The investigators have devised an auto-titrating oxygen system (intelligent oxygen therapy [iO2Ts]) which delivers variable flow oxygen to maintain a pre-set specific oxygen saturation ( SpO2) target. The system can avoid the dual hazards of hypoxia and hyperoxia and potentially optimise LTOT. 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.

Official Title
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The Assessment of Intelligent Oxygen Therapy (iO2T) in Patients With Respiratory Failure on Long-term Oxygen Therapy During Sleep

Conditions
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Respiration Failure

Intervention / Treatment
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* Device: Intelligent oxygen therapy system (iO2Ts)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: On or eligible for long-term oxygen therapy Exclusion Criteria: Nocturnal use of non-invasive ventilation (NIV) or continuous positive airways pressure (CPAP) A diagnosis of obstructive sleep apnoea A diagnosis of a neuromuscular disease Daytime partial pressure of carbon dioxide > 8.0 kPa Inability to consent for the study Exacerbation of the underlying lung disease or chest infection in the previous 4 weeks Pregnancy Severe co-morbidities Patients with a tracheostomy Long-term oxygen therapy flow rate ≥ 4 litre per minute Inability to understand the English language

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sleep study on usual long-term oxygen therapy flow rate<br>Participants will have a sleep study on their usual LTOT flow rate. | |
| Experimental: Sleep study on the intelligent oxygen therapy system<br>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. | Device: Intelligent oxygen therapy system (iO2Ts)<br> <br> * Other names: Auto-titrating oxygen system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of time spent with SpO2 <90% during sleep (%) | The difference in percentage time spent at SpO2 less than 90% during sleeping usual LTOT and iO2T (measured as %) | 10 hours in bed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of time spent with SpO2 >96% during sleep (%) | The percentage of time during sleep with an SpO2 value >96% (measured as %) | 10 hours in bed | 
| The mean transcutaneous carbon dioxide level during sleep (measured in kPa) | Mean level of transcutaneous carbon dioxide level during sleep (measured in kPa) | 10 hours in bed | 
| The peak transcutaneous carbon dioxide level during sleep measures in kPa | The maximum level of transcutaneous carbon dioxide during sleep (measured in kPa) | 10 hours in bed | 
| The mean sleep SpO2 | The mean level of SpO2 during sleep (measured in SpO2 %) | 10 hours during sleep | 
| Sleep quality as measured on a visual analogue scale (0 - 100mm). | The morning after the sleep study, participants will complete a visual analogue scale of their sleep quality. The visual analogue scale is on a A4 paper, it is a straight line of 100mm. | 10 hours in bed | 
| Total Sleep time | The total amount of time spent in sleep confirmed by polysomnography (measured in minutes) | 10 hours during sleep | 
| Sleep efficiency | This is the total amount of time the patients actually slept divided by the total time they were in bed (measured as a percentage). | 10 hours in bed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-term oxygen therapy, Intelligent oxygen therapy system, Auto-titrating oxygen system