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Intelligent Oxygen Therapy During Sleep

Primary Purpose

Respiration Failure

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intelligent oxygen therapy system (iO2Ts)
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiration Failure focused on measuring Long-term oxygen therapy, Intelligent oxygen therapy system, Auto-titrating oxygen system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • On or eligible for long-term oxygen therapy

Exclusion Criteria:

  1. Nocturnal use of non-invasive ventilation (NIV) or continuous positive airways pressure (CPAP)
  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

Sites / Locations

  • Royal Brompton and Harefield NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Sleep study on usual long-term oxygen therapy flow rate

Sleep study on the intelligent oxygen therapy system

Arm Description

Participants will have a sleep study on their usual LTOT flow rate.

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.

Outcomes

Primary Outcome Measures

The percentage of time spent with SpO2 <90% during sleep

Secondary Outcome Measures

The percentage of time spent with SpO2 >96% during sleep
The mean transcutaneous carbon dioxide level during sleep
The peak transcutaneous carbon dioxide level during sleep
The mean sleep SpO2
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.
Total Sleep time
Sleep efficiency. This is the total amount of time the patients actually slept divided by the total time they were in bed.

Full Information

First Posted
November 25, 2016
Last Updated
December 2, 2016
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT02983565
Brief Title
Intelligent Oxygen Therapy During Sleep
Official Title
The Assessment of Intelligent Oxygen Therapy (iO2T) in Patients With Respiratory Failure on Long-term Oxygen Therapy During Sleep
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration Failure
Keywords
Long-term oxygen therapy, Intelligent oxygen therapy system, Auto-titrating oxygen system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep study on usual long-term oxygen therapy flow rate
Arm Type
No Intervention
Arm Description
Participants will have a sleep study on their usual LTOT flow rate.
Arm Title
Sleep study on the intelligent oxygen therapy system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intelligent oxygen therapy system (iO2Ts)
Other Intervention Name(s)
Auto-titrating oxygen system
Primary Outcome Measure Information:
Title
The percentage of time spent with SpO2 <90% during sleep
Time Frame
10 hours during sleep
Secondary Outcome Measure Information:
Title
The percentage of time spent with SpO2 >96% during sleep
Time Frame
10 hours during sleep
Title
The mean transcutaneous carbon dioxide level during sleep
Time Frame
10 hours during sleep
Title
The peak transcutaneous carbon dioxide level during sleep
Time Frame
10 hours during sleep
Title
The mean sleep SpO2
Time Frame
10 hours during sleep
Title
Sleep quality as measured on a visual analogue scale (0 - 100mm).
Description
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.
Time Frame
10 hours during sleep
Title
Total Sleep time
Time Frame
10 hours during sleep
Title
Sleep efficiency. This is the total amount of time the patients actually slept divided by the total time they were in bed.
Time Frame
10 hours during sleep

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad E Moghal, MBBS
Phone
020 7352 8121
Ext
4183
Email
m.moghal@rbht.nhs.uk
Facility Information:
Facility Name
Royal Brompton and Harefield NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad E Moghal, MBBS
Phone
020 7352 8121
Ext
4183
Email
m.moghal@rbht.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD.

Learn more about this trial

Intelligent Oxygen Therapy During Sleep

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