Patient Experience and Technical Success of Community Sleep Studies

Obstructive Sleep Apnea Clinical Trial

— PETSOCSS  

Official title:

Patient Experience and Technical Success of Community Sleep Studies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05432102
• Other study ID #: P02530
• Status: Recruiting
• Start date: May 4, 2022
• Est. completion date: July 2022

Study information

• Verified date: June 2022
• Source: Papworth Hospital NHS Foundation Trust
• Contact: Katharine Woodall
• Phone: +44 1223 639636
• Email: katharine.woodall[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Pulse oxymetry
Diagnostic intervention to diagnose OSA.
• Respiratory polygraphy
Diagnostic intervention to diagnose OSA.

Locations

Country	Name	City	State
United Kingdom	Royal Papworth Hospital NHS Foundation Trust	Cambridge

Sponsors (3)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust	CRN Eastern, Iceni Laboratories

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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?	3 months
Secondary	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?	3 months