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Completed

NCT Number: NCT02983565

Intelligent 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.

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Key information

Conditions

Respiration Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Brompton and Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intelligent oxygen therapy system (iO2Ts)

Device

Other names: Auto-titrating oxygen system

Primary outcomes

  1. 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 %)

Secondary outcomes

  1. The percentage of time spent with SpO2 >96% during sleep (%)

    Time frame: 10 hours in bed

    The percentage of time during sleep with an SpO2 value >96% (measured as %)

  2. The mean transcutaneous carbon dioxide level during sleep (measured in kPa)

    Time frame: 10 hours in bed

    Mean level of transcutaneous carbon dioxide level during sleep (measured in kPa)

  3. The peak transcutaneous carbon dioxide level during sleep measures in kPa

    Time frame: 10 hours in bed

    The maximum level of transcutaneous carbon dioxide during sleep (measured in kPa)

  4. The mean sleep SpO2

    Time frame: 10 hours during sleep

    The mean level of SpO2 during sleep (measured in SpO2 %)

  5. Sleep quality as measured on a visual analogue scale (0 - 100mm).

    Time frame: 10 hours in bed

    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.

  6. Total Sleep time

    Time frame: 10 hours during sleep

    The total amount of time spent in sleep confirmed by polysomnography (measured in minutes)

  7. Sleep efficiency

    Time frame: 10 hours in bed

    This is the total amount of time the patients actually slept divided by the total time they were in bed (measured as a percentage).

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2016
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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