Automated Titration for Home Oxygen Therapy

NCT06153485 | Enrolling By Invitation

• 1 other identifier: AutoO2x
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic respiratory disease may be prescribed oxygen therapy. Currently, the dose of oxygen flow is fixed (FixedO2) depending on activity level i.e. rest, physical activity and sleep. Automated Titration of Oxygen (AutoO2) is a closed-loop system in which the oxygen flow to the patient is continuously machine adjusted to meet the patient's immediate needs on the basis of signals from pulse oximetry (SpO2). The purpose of this study is to examine if automated oxygen control based on pulse oximetry provided to participants is superior to prescribed fixed oxygen flow in keeping SpO2 within the intended target interval of 92 to 96% arterial oxygen saturation.

Conditions

Chronic Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• Daily time spent normoxic as defined by an arterial oxygen saturation measured by pulse oximetry (SpO2), between 92 to 96%, will be expressed a function of total time recorded SpO2.

  SpO2 will be recorded throughout the day (24 hours). The primary outcome measure equals the daily time with 92%≥SpO2≤ 96% (numerator) divided by the total daily time of measured SpO2 (denominator).

  24 hour

Study Arms (2)

AutoO2

EXPERIMENTAL

Automated Titration of Oxygen (Auto-O2) using a closed-loop system in which the oxygen flow to the participant is continuously adjusted on the basis of pulse oximetry signals to maintain a target range of oxygen saturation to meet the patient's immediate needs.

Device: AutoO2

FixedO2

ACTIVE COMPARATOR

Fixed flow oxygen delivery administered using manual flow meters according to standard clinical procedures.

Other: FixedO2

Interventions

AutoO2 DEVICE

Automated Titration of Oxygen (Auto-O2) using a closed-loop system in which the oxygen flow to the participant is continuously adjusted on the basis of pulse oximetry signals to maintain a target range of oxygen saturation to meet the participant's immediate needs.

Also known as: HOT-100 (O2matic Ltd, Herlev, Denmark)

AutoO2

FixedO2 OTHER

Fixed flow oxygen delivery administered using manual flow meters according to standard clinical procedures.

FixedO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable chronic respiratory disease
• current prescription for supplemental oxygen therapy

You may not qualify if:

• characteristics that compromise the validity of oximetry
• inability to communicate in English

Sponsors & Collaborators

• West Park Healthcare Centre: lead

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Program in Respiratory Rehabilitation

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: December 1, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)