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Prolonged Overnight Oximetry in Obstructive Sleep Apnoea

NCT04287751 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-02-27

No results posted yet for this study

Summary

This study is looking at the way in which patients with obstructive sleep apnoea (OSA) are diagnosed. The investigators current practice is to offer patients who are referred to the sleep centre with possible sleep apnoea a single night's oximetry recording. A decision is then made based on this screening test as to whether the patient has OSA, does not have OSA or requires a further investigation. There can be significant variation in the severity of OSA between nights. This study is designed to investigate if recording data from multiple nights will give any better indication on the presence and severity of obstructive sleep apnoea. Patients referred for overnight oximetry recordings that report excessive daytime sleepiness are eligible to enter the trial.

On enrolment participants will all undergo a single night recording with the oximetry device currently in use by the recruiting sleep centre. In addition they will be asked to wear the prolonged recording oximeter (PRO) that allows for multiple nights data to be stored, and continue wearing this for a total of four nights. On returning both oximetry devices, this data will then be analysed and if it demonstrates evidence of OSA participants will return to the standard clinical pathway and be offered a trial of treatment with continuous positive airway pressure (CPAP) therapy.

If no evidence of OSA is seen participants will also revert back to the standard clinical pathway, which may involve a further inpatient sleep investigation being arranged.

The number of patients identified as having OSA based on the single first night recording will be compared to those identified as having OSA only after the additional nights recording.

All participants will return to the current standard pathway of care on leaving the trial.

Conditions

Interventions

DEVICE

CheckMeO2 Oximeter

Simultaneous recording with a current standard oximeter (Minolta i300) and prolonged recording device. Comparison of data from first night and incidence of obstructive sleep apnoea identified from additional nights of recording identified.

Sponsors & Collaborators

  • Somerset NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Justin Pepperell · Somerset NHS Foundation Trust

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2021-03-31
Completion
2021-05-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04287751 on ClinicalTrials.gov