An observational study in Obstructive Sleep Apnea, sponsored by Papworth Hospital NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-27.
Sponsored by Papworth Hospital NHS Foundation Trust · Observational
This study looks at the quality of the common mechanisms used to diagnose obstructive sleep apnoea (OSA) by patients in their own homes. These are pulse oximetry as a stand alone measurement and multi-channel respiratory studies that measure oximetry but also record some combination of signals including airflow at the mouth and or nose, chest and abdominal expansion, body position and snoring. This study will examine the patient acceptability of these methods and the proportion of studies that achieve various levels of technical quality ranging from a full night with all data available to a completely failed study and categories in between.
There is a study underway to develop a non-contact detector of breathing (SafeScan) as a new method of diagnosing obstructive sleep apnoea (OSA). There are a number of different methods already available to achieve this end but one proposed advantage of the new SafeScan device is that it will not affect sleep quality and because there are no measuring devices attached to the patient it is less likely that the signal will be lost in the night due to the normal movements of sleep. However there are no data available that quantify these factors as an issue for the current techniques and devices.
The proving study for SafeScan is a comparison of the ability of the device to measure sleep apnoea compared to full in-hospital polysomnography (PSG) and one outcome will be the proportion of studies that have lost data. However the future use of the SafeScan device will be in the community. The common diagnostics used by patients in their own homes are pulse oximetry as a stand alone measurement and multi-channel respiratory studies that measure oximetry but also record some combination of signals including airflow at the mouth and or nose, chest and abdominal expansion, body position and snoring. We propose a study to examine the patient acceptability of these methods and the proportion of studies that achieve various levels of technical quality ranging from a full night with all data available to a completely failed study and categories in between. In addition there will be an analysis of the results to explore whether there are features of the patients such as age and obesity that make technical success or failure of the studies more likely.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.
This study's planned enrollment of 200 is above the median of 104 across 648 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Papworth Hospital NHS Foundation Trust is the lead sponsor of 62 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing a home sleep study at Royal Papworth Hospital
Patient able to provide assent by completion of the Research Questionnaire Adult patients (≥ 18 years of age) Patients undergoing a home sleep study
Exclusion Criteria:
Patients unable to complete questionnaires due to language or other barriers
This label will used to describe participants having respiratory polygraphy at Royal Papworth Hospital over a 3 month period.
Diagnostic Test: Respiratory polygraphy
This label will used to describe participants having pulse oximetry at Royal Papworth Hospital over a 3 month period.
Diagnostic Test: Pulse oxymetry
Diagnostic intervention to diagnose OSA.
Diagnostic intervention to diagnose OSA.
Satisfactory sleep studies
The proportion of home studies to diagnose sleep apnoea that are satisfactory without disruption to the patient's sleep or loss of signals to an extent that make the results unreliable.
Time frame: 3 months
Extent of sleep disruption
What proportion of patients report sleep disruption due to: oximeter probe / nasal cannula / thermistor / chest band /abdominal band / the recording device?
Time frame: 3 months
Extent of signal failure
What proportion of studies failed due to loss of signal from: oximeter probe / nasal cannula / thermistor / chest band /abdominal band / the recording device?
Time frame: 3 months
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Papworth Hospital NHS Foundation Trust