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

NCT04018547 | Unknown FDA Device

• 1 other identifier: 265604
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Obstructive Sleep Apnea

Keywords

Screening, patient convenience

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient comfort and compliance

  Three months

Interventions

Patient wears a wrist sensor oximeter device for one to two nights. DEVICE

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).

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxitone Medical Ltd.: lead
• The London Sleep Centre: collaborator

Study Sites (1)

London Sleep Centre

London, W1G6BF, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Leon Eisen, PhD

CONTACT

+97278346731; Leon.eisen@oxitone.com

Werner Stipp, MBCHB MFOM DIH

CONTACT

+447597558426; Werner.stipp@oxitone.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 12, 2019
• Study Start: September 17, 2019
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Three months
• Access Criteria: Contact Oxitone for access

Locations

GB (1)