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| Name | Class |
|---|---|
| The London Sleep Centre | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Thirty consecutive patients referred to the sleep Centre for screening for sleep apnoea that consented to involvement in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leon Eisen, PhD | Contact | +97278346731 | Leon.eisen@oxitone.com | |
| Werner Stipp, MBCHB MFOM DIH | Contact | +447597558426 | Werner.stipp@oxitone.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Sleep Centre | London | W1G6BF | United Kingdom |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
All IPD that underlie results in a publication will be shared with other researchers.
Personal identifiable data will not be shared with other researchers.
Three months
Contact Oxitone for access
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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De-identified data for primary and secondary outcome measures |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |