Prolonged Overnight Oximetry in Obstructive Sleep Apnoea

NCT04287751 | Unknown

• 1 other identifier: 20/LO/0055
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnoea; Overnight Oximetry

Outcome Measures

Primary Outcomes (1)

• Incidence of OSA on 1 night vs 4 nights Oximetry

  To compare the incidence of OSA using current single night recording versus multiple night recordings

  4 days

Secondary Outcomes (2)

• To compare the adherence rates to CPAP at 1 month follow-up

  1 month

• To assess the tolerability of prolonged oximetry screening for patients

  4 days

Study Arms (1)

Overnight Oximetry

OTHER

Participants record simultaneously overnight oximetry on night 1 and continue with prolonged recordings alone for a total of 4 nights

Device: CheckMeO2 Oximeter

Interventions

CheckMeO2 Oximeter DEVICE

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.

Overnight Oximetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to participate and give informed consent to participate
• Male or Female aged 18 years or older
• Referral letter or request to sleep service reports an Epworth Sleepiness Score of greater than 9 or reason for the referral is 'excessive daytime sleepiness'

You may not qualify if:

• Significant cardiovascular or respiratory co-morbidities
• Suspected hypoventilation or sleep disordered breathing
• Previously used Non-invasive ventilation
• In the Investigators opinion an alternative diagnostic test should be offered as first line e.g. referral information suggests an inpatient sleep study is required.

Sponsors & Collaborators

• Somerset NHS Foundation Trust: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Justin Pepperell

  Somerset NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Davidson, MBBCh

CONTACT

07867 408463; james.davidson@tst.nhs.uk

Justin Pepperell

CONTACT

01823 344635; justin.pepperell@tst.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician in Respiratory and General Medicine; Honorary Senior Lecturer University of Exeter; Director of Department of Clinical Research; Secretary of the British Thoracic Society

Model Details: Recruiting participants undergoing overnight oximetry on a single night to have additional 4 nights of recording with a prolonged recording oximeter device

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 27, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share