Intelligent Oxygen Therapy During Sleep

Respiration Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983565
• Other study ID #: 15IC2590
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 2017

Study information

• Verified date: November 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiration Failure
• Respiratory Insufficiency

Intervention

Device:
• Intelligent oxygen therapy system (iO2Ts)

Locations

Country	Name	City	State
United Kingdom	Royal Brompton and Harefield NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	The mean sleep SpO2	The mean level of SpO2 during sleep (measured in SpO2 %)	10 hours during sleep
Secondary	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
Secondary	Total Sleep time	The total amount of time spent in sleep confirmed by polysomnography (measured in minutes)	10 hours during sleep
Secondary	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

External Links

•   Completed PhD thesis of M Moghall including results of Intelligent Oxygen therapy during sleep study