Patient Experience and Technical Success of Community Sleep Studies

NCT ID: NCT05432102

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2022-07-31

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants having respiratory polygraphy

This label will used to describe participants having respiratory polygraphy at Royal Papworth Hospital over a 3 month period.

Respiratory polygraphy

Intervention Type: DIAGNOSTIC_TEST

Diagnostic intervention to diagnose OSA.

Participants having pulse oximetry

This label will used to describe participants having pulse oximetry at Royal Papworth Hospital over a 3 month period.

Pulse oxymetry

Intervention Type: DIAGNOSTIC_TEST

Diagnostic intervention to diagnose OSA.

Interventions

Pulse oxymetry

Diagnostic intervention to diagnose OSA.

Intervention Type: DIAGNOSTIC_TEST

Respiratory polygraphy

Diagnostic intervention to diagnose OSA.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iceni Laboratories

UNKNOWN

Sponsor Role: collaborator

CRN Eastern

UNKNOWN

Sponsor Role: collaborator

Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Papworth Hospital NHS Foundation Trust

Cambridge, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Katharine Woodall

Role: CONTACT

katharine.woodall@nhs.net

+44 1223 639636

Joanna Raynor

Role: CONTACT

joanna.raynor1@nhs.net

+44 1223 639699

Facility Contacts

Earl Palas

Role: primary

earl.palas@nhs.net

+44 1223 638410

Other Identifiers

P02530

Identifier Type: -

Identifier Source: org_study_id