NCT02983565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

November 25, 2016

Last Update Submit

November 22, 2023

Conditions

Respiration Failure

Keywords

Long-term oxygen therapyIntelligent oxygen therapy systemAuto-titrating oxygen system

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

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

    10 hours in bed

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

    10 hours in bed

  • The peak transcutaneous carbon dioxide level during sleep measures in kPa

    10 hours in bed

  • The mean sleep SpO2

    10 hours during sleep

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

    10 hours in bed

  • +2 more secondary outcomes

Study Arms (2)

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.

Device: Intelligent oxygen therapy system (iO2Ts)

Interventions

Intelligent oxygen therapy system (iO2Ts)DEVICE
Also known as: Auto-titrating oxygen system
Sleep study on the intelligent oxygen therapy system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • On or eligible for long-term oxygen therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton and Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Anita K Simonds

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant not aware using iO2T or Fixed flow oxygen
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2016

First Posted

December 6, 2016

Study Start

October 1, 2016

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

No plan to share IPD.

Locations

GB(1)