Status:
UNKNOWN
Investigating a Wrist-sensor Oximeter to Screen for Sleep Apnoea.
Lead Sponsor:
Oxitone Medical Ltd.
Collaborating Sponsors:
The London Sleep Centre
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-68 years
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...
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 referre...
Eligibility Criteria
Inclusion
- Thirty consecutive patients referred to the sleep Centre for screening for sleep apnoea that consented to involvement in the study.
Exclusion
- 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
Key Trial Info
Start Date :
September 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 17 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04018547
Start Date
September 17 2019
End Date
December 17 2019
Last Update
July 12 2019
Active Locations (1)
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1
London Sleep Centre
London, United Kingdom, W1G6BF