NCT04018547

Investigating a Wrist-sensor Oximeter to Screen for Sleep Apnoea.

Investigating the Use of a Wrist-sensor Pulse Oximeter to Screen for Obstructive Sleep Apnoea.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Oxitone Medical Ltd. · Industry
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

The primary study objective is to investigate sensitivity and specificity of a wrist sensor pulse oximeter (the Oxitone Medical Oxitone 1000M device) to screen for obstructive sleep apnoea. This study will involve thirty participants attending a sleep centre suspected of suffering from obstructive sleep apnoea (case finding screening). The secondary objective is to assess patient convenience with the screening procedure.

Detailed description

This is an observational study to assess the sensitivity and specificity of a wrist sensor pulse oximeter (Oxitone Medical Oxitone 1000M) to identify obstructive sleep apnoea cases in patients referred to the London Sleep Centre (case finding screening, or case only study). The wrist sensor pulse oximeter streams data (pulse rate, heart rate variability (HRV), blood oxygen saturation levels (SPO2), actigraphy data and skin temperature data) to a software application using bluetooth connectivity to be stored in a securely encrypted database cloud for analysis. The investigators at the sleep centre will be masked when analysing the data from the wrist sensor pulse oximeter when deciding on diagnosis of obstructive sleep apnoea. Data from the wrist sensor oximeter device will be statistically compared with the data from a conventional PPG fingertip oximeter and Peripheral Arterial Tonometry device currently in use. The study outcome will be whether the wrist sensor pulse oximeter device could be used in patients to screen reliably for obstructive sleep apnoea. The study also will include patient feedback on convenience of the screening procedure. The study will not affect routine patient medical management and care for patients assessed at the sleep centre.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Patient wears a wrist sensor oximeter device for one to two nights.	Patients will be asked to complete a study questionnaires of STOPBANG, SCI-8 (Sleep Condition Indicator-8 questionnaire for insomnia), Epworth questionnaires and medical history. The clinician will record blood pressure, pulse rate and regularity, body mass index and neck circumference. Subjects will be required to wear the wrist sensor pulse oximeter for 1-2 nights. The Oxitone 1000M device measures pulse rate, blood oxygen saturation and movement. The oxygen desaturation events from the wrist sensor device will be statistically compared with the diagnosis assessed using the conventional PPG oximetry, Peripheral Arterial Tonometry and clinical assessment. (clinicians will be masked when analysing the data from the wrist sensor pulse device).

Timeline

• Start date: 2019-09-17
• Primary completion: 2019-12-17
• Completion: 2019-12-17
• First posted: 2019-07-12
• Last updated: 2019-07-12

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study