MedTrace Logo

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

NCT04018547 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2019-07-12

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • The London Sleep Centre

    collaborator UNKNOWN

  • Oxitone Medical Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2019-12-17
Completion
2019-12-17
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018547 on ClinicalTrials.gov