Rationale Patients with COPD on long″term oxygen therapy (LTOT) have an unmet need for oxygen adjustments during sleep, rest, and activity, documented by continuous monitoring of oxygen saturation. While emerging technology enables automated adjustments, its feasibility in home settings remains uncertain. This randomized crossover trial evaluated the feasibility and preliminary effects of continuous automated oxygen titration in the homes of patients on LTOT. Methods The intervention involved four days of automated oxygen titration targeting a SpO₂ of 90-94% using a Bluetooth-connected electronic device and wrist pulse oximeter, forming a closed-loop system. Oxygen flow (0.9″6.8 L/min) was continuously adjusted based on SpO₂. During the control period, patients received their usual fixed dose oxygen. Feasibility was defined as successful automated titration time and time spent with normoxia. Changes in health status were measured using the Clinical COPD Questionnaire (CCQ). Results Twelve patients on LTOT (2.0±0.8 L/min) were included, with more than 217,000 paired SpO2 and oxygen flow data points collected per patient. Oxygen flow was automatically adjusted for a median (IQR) of 77 (68.0″84.3) hours, covering 83% of the time. Time within target saturation increased significantly from 52% (42″63) to 86% (75″90) during intervention, with all patients utilizing the full available flow range. The CCQ score improved by 0.74±0.47 points, p <0.001. Conclusion Automated home oxygen titration is feasible, achieving more time with normoxia, but it required a wide flow range and continuous monitoring. The patients reported notable reductions in COPD symptoms.

The principal investigator has no conflicts of interest. One of the investigators (Ejvind Frausing Hansen) is a co-inventor of the closed-loop device and holds shares in O2matic Ltd. Neither the company nor the funders had influence on the protocol, the data analysis, or the writing of the scientific paper. Apart from the above conflict of interest the remaining investigators have none.

NCT05556187

The study was funded by Innovation Fund Denmark grant nr. 8056-00054B, Swedish Respiratory Society (SMLF) and The Association of Danish Physiotherapists Research Fund.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by The Committees on Health Research Ethics in the Capital Region of Denmark (H-22032988) and the Danish Data Protection Agency j.nr. P-2022-625.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Public deposition of raw data points is not possible due to Denmarks national legislation (Data Protection Act section 10 and Data Disclosure Proclamation Act) which outline that we can only transfer pseudonymized data to the Journal after the Data Protection Authorities approval (Data Protection Act section 10, part 3, nr. 3.). Reviewers and others may obtain access to the data by request, and after the Danish Data Protection Agency has approved of the data transfer from the Capital Region. If others are to gain access to the pseudonymized data, they shall ensure that is an adequate legal basis to share the Capital Regions data and ensure that the data is only being processed for scientific research purposes.