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出境医 / 临床实验 / Investigating a Wrist-sensor Oximeter to Screen for Sleep Apnoea.

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

Study Description
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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea 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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Investigating the Use of a Wrist-sensor Pulse Oximeter to Screen for Obstructive Sleep Apnoea.
Estimated Study Start Date : September 17, 2019
Estimated Primary Completion Date : December 17, 2019
Estimated Study Completion Date : December 17, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. obstructive sleep apnoea screening [ Time Frame: Three months ]
    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).


Secondary Outcome Measures :
  1. Patient comfort and compliance [ Time Frame: Three months ]
    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"


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date July 10, 2019
First Posted Date July 12, 2019
Last Update Posted Date July 12, 2019
Estimated Study Start Date September 17, 2019
Estimated Primary Completion Date December 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2019) 		obstructive sleep apnoea screening [ Time Frame: Three months ]
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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 11, 2019) 		Patient comfort and compliance [ Time Frame: Three months ]
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"
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigating a Wrist-sensor Oximeter to Screen for Sleep Apnoea.
Official Title Investigating the Use of a Wrist-sensor Pulse Oximeter to Screen for Obstructive Sleep Apnoea.
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Obstructive Sleep Apnea
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).
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 11, 2019) 		30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 17, 2019
Estimated Primary Completion Date December 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 68 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Leon Eisen, PhD +97278346731 Leon.eisen@oxitone.com
Contact: Werner Stipp, MBCHB MFOM DIH +447597558426 Werner.stipp@oxitone.com
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04018547
Other Study ID Numbers 265604
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Three months
Access Criteria: Contact Oxitone for access
URL: http://www.oxitone.com
Responsible Party Oxitone Medical Ltd.
Study Sponsor Oxitone Medical Ltd.
Collaborators The London Sleep Centre
Investigators Not Provided
PRS Account Oxitone Medical Ltd.
Verification Date July 2019

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