Patient Experience and Technical Success of Community Sleep Studies

• Conditions: Obstructive Sleep Apnea
• Interventions: Diagnostic Test: Pulse oxymetry; Diagnostic Test: Respiratory polygraphy

• Registration Number: NCT05432102
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-05-04
• Status Verified: 2022-06
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Last Update Submitted: 2022-06-20
• Study First Posted: 2022-06-27
• Last Update Posted: 2022-06-27
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants having pulse oximetry	Pulse oxymetry	This label will used to describe participants having pulse oximetry at Royal Papworth Hospital over a 3 month period.
Participants having respiratory polygraphy	Respiratory polygraphy	This label will used to describe participants having respiratory polygraphy at Royal Papworth Hospital over a 3 month period.

Primary Outcome Measures

Name	Time	Method
Satisfactory sleep studies	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Extent of signal failure	3 months	What proportion of studies failed due to loss of signal from: oximeter probe / nasal cannula / thermistor / chest band /abdominal band / the recording device?
Extent of sleep disruption	3 months	What proportion of patients report sleep disruption due to: oximeter probe / nasal cannula / thermistor / chest band /abdominal band / the recording device?

Trial Locations

Locations (1)

Royal Papworth Hospital NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom