Intelligent Oxygen Therapy During Sleep

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.

Study Overview

• Status: Unknown
• Conditions: Respiration Failure
• Intervention / Treatment: Device: Intelligent oxygen therapy system (iO2Ts)

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 Type: Interventional
• Enrollment (Anticipated): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad E Moghal, MBBS; Phone Number: 4183 020 7352 8121; Email: m.moghal@rbht.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Recruiting
    • Royal Brompton and Harefield NHS Foundation Trust
    • Contact: Mohammad E Moghal, MBBS; Phone Number: 4183 020 7352 8121; Email: m.moghal@rbht.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Sleep study on usual long-term oxygen therapy flow rate; Participants will have a sleep study on their usual LTOT flow rate.
Experimental: Sleep study on the intelligent oxygen therapy system; 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); Other Names: Auto-titrating oxygen system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of time spent with SpO2 <90% during sleep	10 hours during sleep

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of time spent with SpO2 >96% during sleep		10 hours during sleep
The mean transcutaneous carbon dioxide level during sleep		10 hours during sleep
The peak transcutaneous carbon dioxide level during sleep		10 hours during sleep
The mean sleep 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 during sleep
Total Sleep time		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.		10 hours during sleep

Collaborators and Investigators

• Sponsor: Imperial College London

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: November 25, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimate): December 6, 2016

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Long-term oxygen therapy; Intelligent oxygen therapy system; Auto-titrating oxygen system
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 15IC2590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD.