Respiration FailureNCT02983565
Intelligent Oxygen Therapy During Sleep
A study testing Intelligent oxygen therapy system (iO2Ts) in people with Respiration Failure, run by Imperial College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration Failure
- What is being tested?
- Intelligent oxygen therapy system (iO2Ts)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On or eligible for long-term oxygen therapy
Who cannot join
- 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
Show all 11Show fewer
- Pregnancy
- Severe co-morbidities
- Patients with a tracheostomy
- Long-term oxygen therapy flow rate ≥ 4 litre per minute
- Inability to understand the English language
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton and Harefield NHS Foundation Trust
London, SW3 6NP
About this study
Official title: The Assessment of Intelligent Oxygen Therapy (iO2T) in Patients With Respiratory Failure on Long-term Oxygen Therapy During Sleep
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.
Read the detailed description
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.
- Conditions
- Respiration Failure
- Being tested
- Intelligent oxygen therapy system (iO2Ts)
- Keywords
- Long-term oxygen therapy, Intelligent oxygen therapy system, Auto-titrating oxygen system
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent oxygen therapy system (iO2Ts)Device
Also called Auto-titrating oxygen system
| Study group | Role | What they receive |
|---|---|---|
| Sleep study on usual long-term oxygen therapy flow rate | No intervention | Participants will have a sleep study on their usual LTOT flow rate. |
| Sleep study on the intelligent oxygen therapy system | Experimental | 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. Receives: Device: Intelligent oxygen therapy system (iO2Ts) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %)
Measured: 10 hours in bed
Secondary outcomes (7)
The percentage of time spent with SpO2 >96% during sleep (%)
The percentage of time during sleep with an SpO2 value >96% (measured as %)
Measured: 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)
Measured: 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)
Measured: 10 hours in bed
The mean sleep SpO2
The mean level of SpO2 during sleep (measured in SpO2 %)
Measured: 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.
Measured: 10 hours in bed
Total Sleep time
The total amount of time spent in sleep confirmed by polysomnography (measured in minutes)
Measured: 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).
Measured: 10 hours in bed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration FailureStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita K Simonds, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983565
- Sponsor's protocol ID
- 15IC2590
- Status last verified
- Nov 2023
- First submitted
- 25 Nov 2016
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Intelligent Oxygen Therapy (iO2T) in Patients With Respiratory Failure on Long-term Oxygen Therapy During Sleep
- ClinicalTrials.gov ID
- NCT02983565
- Acronym / sponsor ID
- 15IC2590
- Conditions
- Respiration Failure
- Keywords
- Long-term oxygen therapy, Intelligent oxygen therapy system, Auto-titrating oxygen system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep study on usual long-term oxygen therapy flow rate | No intervention | –Participants will have a sleep study on their usual LTOT flow rate. |
| Sleep study on the intelligent oxygen therapy system | Experimental | Device: Intelligent oxygen therapy system (iO2Ts)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- On or eligible for long-term oxygen therapy
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent oxygen therapy system (iO2Ts)Also: Auto-titrating oxygen system | Device | Sleep study on the intelligent oxygen therapy system |
Primary outcome
The percentage of time spent with SpO2 <90% during sleep (%)
Time frame: 10 hours in bed
The difference in percentage time spent at SpO2 less than 90% during sleeping usual LTOT and iO2T (measured as %)
7 secondary outcomes
The percentage of time spent with SpO2 >96% during sleep (%)
Time frame: 10 hours in bed
The mean transcutaneous carbon dioxide level during sleep (measured in kPa)
Time frame: 10 hours in bed
The peak transcutaneous carbon dioxide level during sleep measures in kPa
Time frame: 10 hours in bed
The mean sleep SpO2
Time frame: 10 hours during sleep
Sleep quality as measured on a visual analogue scale (0 - 100mm).
Time frame: 10 hours in bed
Total Sleep time
Time frame: 10 hours during sleep
Sleep efficiency
Time frame: 10 hours in bed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Completed PhD thesis of M Moghall including results of Intelligent Oxygen therapy during sleep studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita K Simonds principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent oxygen therapy system (iO2Ts) in people with Respiration Failure, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of time spent with SpO2 <90% during sleep (%) (time frame: 10 hours in bed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.