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.

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Patient wears a wrist sensor oximeter device for one to two nights.

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Leon Eisen, PhD; Phone Number: +97278346731; Email: Leon.eisen@oxitone.com
• Study Contact Backup: Name: Werner Stipp, MBCHB MFOM DIH; Phone Number: +447597558426; Email: Werner.stipp@oxitone.com

Study Locations

• United Kingdom
  • London, United Kingdom, W1G6BF
    • London Sleep Centre
    • Contact: Irshaad Ebrahim, MBCHB FRCPsych; Phone Number: +442077250523; Email: Info@londonsleepcentre.com
    • Principal Investigator: Werner Stipp, MBCHB MFOM DIH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Thirty consecutive patients referred to the sleep Centre for screening for sleep apnoea that consented to involvement in the study.

Description

Inclusion Criteria:

• Thirty consecutive patients referred to the sleep Centre for screening for sleep apnoea that consented to involvement in the study.

Exclusion Criteria:

• Patients who are unable to give written informed consent.
• anaemia or dysfunctional hemoglobin
• upper limb complaints affecting the ability to wear the watch like wrist sensor device such as tenderness, deformity or swelling, skin complaints such as ulceration, swelling or skin breaks
• impairment in circulation in the left upper limb (active Raynauds or other vascular impairment)
• neurological conditions such as tremor or convulsions
• Medical conditions likely to affect the blood oxygen such as chronic obstructive pulmonary disease (COPD) and chronic asthma
• Neurological conditions likely to affect breathing such as stroke
• Conditions likely to affect autonomic nervous system such as diabetes mellitus

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
obstructive sleep apnoea screening	Sensitivity and specificity of the wrist sensor oximeter to screen for obstructive sleep apnoea by (A) comparing the SPO2 3% and 4 % dip rates of the conventional fingertip photoplethysmography(PPG) oximeter to the 3% and 4% dip rates of the wrist sensor pulse oximeter and (B) comparing the final diagnosis of obstructive sleep apnoea (OSA) by a sleep specialist (based on PPG fingertip oximetry and peripheral arterial tonometry), with SPO2 and heart rate variability data from the wrist sensor pulse oximeter. The sleep specialist will be masked from the data of the wrist sensor pulse oximeter. An ROC (receiver operating characteristic) curve will be used for (B).	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient comfort and compliance	To assess patient comfort wearing the wrist sensor pulse oximetry device by administering a questionnaire with responses on a Likert scale to question "the wrist sensor pulse oximeter was comfortable to sleep with"	Three months

Collaborators and Investigators

• Sponsor: Oxitone Medical Ltd.
• Collaborators: The London Sleep Centre

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 17, 2019
• Primary Completion (ANTICIPATED): December 17, 2019
• Study Completion (ANTICIPATED): December 17, 2019

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (ACTUAL): July 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Screening, patient convenience
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 265604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All IPD that underlie results in a publication will be shared with other researchers.

Personal identifiable data will not be shared with other researchers.

• IPD Sharing Time Frame: Three months
• IPD Sharing Access Criteria: Contact Oxitone for access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Study Data/Documents

1. Individual Participant Data Set
   Information comments: De-identified data for primary and secondary outcome measures

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No