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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04018547
• Other study ID #: 265604
• Status: Not yet recruiting
• Start date: September 17, 2019
• Est. completion date: December 17, 2019

Study information

• Verified date: July 2019
• Source: Oxitone Medical Ltd.
• Contact: Leon Eisen, PhD
• Phone: +97278346731
• Email: Leon.eisen[@]oxitone.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	London Sleep Centre	London

Sponsors (2)

Lead Sponsor	Collaborator
Oxitone Medical Ltd.	The London Sleep Centre

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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