Obstructive Sleep ApneaPROXIMONCT04287751
Prolonged Overnight Oximetry in Obstructive Sleep Apnoea
A study testing CheckMeO2 Oximeter in people with Obstructive Sleep Apnea, run by Somerset NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CheckMeO2 Oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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'
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: PROXIMO: A Cohort Study to Investigate the Incidence of Obstructive Sleep Apnoea Using Prolonged Overnight Oximetry in an Unselected Population Referred to Secondary Care Reporting Excessive Daytime Sleepiness
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.
Read more
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.
Read the detailed description
Obstructive sleep apnoea (OSA) is a common condition, effecting an estimated 1.5 million people in the UK and it is believed up to 80% of them may be undiagnosed [1]. During sleep the muscles supporting the upper airway tend to relax and the throat narrows. In patients with OSA the narrowing leads to collapse and pauses in breathing. These pauses in breathing are accompanied by a decrease in arterial oxygen saturation and to overcome the airway collapse the body responds by producing a surge in the sympathetic nervous system. This has the effect of stimulating the pharyngeal muscles to reopen the throat but also causes an increase in heart rate, blood pressure and disrupts the sleep cycle waking the patient up. These repeated disruptions to sleep leads to the patient feeling unrefreshed by sleep, excessively sleepy during the day and at increased risk of a sleepiness-related accident. The repetitive surges in the sympathetic nervous system also contributes to the risk of long term cardiovascular disease. The frequency with which these events occur determines the severity of obstructive sleep apnoea, less than 5 events per hour is considered normal, 5-15 mild, 15-30 moderate and more than 30 severe disease. However the disease severity does not correlate with the degree of symptoms [2] meaning it is important to identify patients even if they have mild and moderate disease.
OSA is effectively treated with continuous positive airway pressure (CPAP) therapy. These machines blow air into the throat through a nose or face mask. This helps to splint the airway open and reduce the disruption to sleep. CPAP is an effective therapy improving sleepiness, snoring, mood and reduces the long term risk of cardiovascular disease seen in untreated patients with OSA.
Full inpatient polysomnography testing is the gold standard investigation for diagnosis and exclusion of OSA [3]. However because polysomnography generally requires a hospital bed, significant technical input to set up and is time intensive to report it is impractical for the large numbers of patients referred to sleep services to undergo this test. Overnight oximetry recording has been established as an effective alternative for screening patients and identifying OSA in many sleep centres [4-6].
For a single test to be effective it needs to be highly sensitive and the condition being investigated should be stable. However significant variation in the severity of obstructive sleep apnoea has been demonstrated from night to night in individual patients [7, 8]. Therefore using oximetry or even polysomnography recording for a single night may not truly reflect the overall condition. Patients with mild and moderate disease show the most significant variations on a night to night basis, as the oxygen desaturation index (ODI, number of times the oxygen saturations dip per hour) rises, i.e. more severe OSA, less night to night variability is observed [9]. When patients with previously diagnosed OSA are withdrawn from CPAP treatment and overnight oximetry performed for two weeks only 22% of participants consistently remain within one severity category. The majority of these patients were in the severe category. Other studies have shown 40-50% of patients changing severity category in two to four nights recordings [7, 10] and that 16-20% of patients would not have received CPAP treatment based on a single night study but did so after repeating between one to three studies [10, 11].
The most clinically relevant distinction to make is between no OSA and mild and moderate OSA as this determines whether a trial of CPAP therapy would be offered. These previous trials suggest it is within this milder spectrum of the disease where a single night's oximetry recording is least reliable and more than one night's recording may be required.
Despite CPAP being a very successful treatment for OSA, adherence rates to treatment are variable [12, 13]. It has also be shown that adherence correlates with OSA severity [14]. In part this poor adherence to treatment suggests imperfect identification of patients. The investigators hypothesise that the current oximetry screening of a single night may not be effectively identifying all those patients who may benefit from CPAP. The investigators aim to identify how many additional patients are identified as having OSA with prolonged, multi-night recordings. A longer period of oximetry recording may improve the identification of those patients who may benefit from CPAP and may help to identify factors that predict a poorer response to CPAP therapy. Therefore this study will follow-up patients to see if those identified by prolonged oximetry screening tests leads to improved adherence to CPAP.
Two different oximeters are used in this study. The Minolta i300 was chosen as it is the current device used within the investigators clinical service. This is not being used for prolonged recordings as the battery life makes it impractical to be used for more than two nights recording. Therefore the CheckMeO2 oximeter was chosen; this has a rechargeable battery and sufficient memory capacity to be used for the required 4 nights of recording.
The CheckMe O2 device records oxygen saturations to nearest whole number every 4 seconds versus the Minolta device recording to one decimal place every second. It is felt that as the average length of a desaturation in obstructive sleep apnoea is 15-20 seconds the CheckMe O2 device should be sufficiently accurate to detect OSA but by performing a simultaneous recording during the first night the investigators hope to establish if this frequency of recording is sufficient.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CheckMeO2 Oximeter
- Keywords
- Obstructive Sleep Apnoea, Overnight Oximetry
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CheckMeO2 OximeterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Overnight Oximetry | Other | Participants record simultaneously overnight oximetry on night 1 and continue with prolonged recordings alone for a total of 4 nights Receives: Device: CheckMeO2 Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 days
Secondary outcomes (2)
To compare the adherence rates to CPAP at 1 month follow-up
Compare the adherence rates to CPAP between those identified after 1 night compared to those identified after a prolonged recording. Adherence will be measured using CPAP machine usage records accessed at the one month follow-up. The mean hours used per night will be compared between the two groups
Measured: 1 month
To assess the tolerability of prolonged oximetry screening for patients
Patient questionnaire feedback comparing tolerability of prolonged recordings. A 10cm Visual analogue scale will be used to assess how tolerable and easy to use each oximeter device is. Higher scores suggest the device is more tolerable.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Recruiting participants undergoing overnight oximetry on a single night to have additional 4 nights of recording with a prolonged recording oximeter device
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Somerset NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Pepperell, Somerset NHS Foundation Trust
- Investigators
- Justin Pepperell, Principal investigator, Somerset NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287751
- Sponsor's protocol ID
- 20/LO/0055
- Acronym
- PROXIMO
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROXIMO: A Cohort Study to Investigate the Incidence of Obstructive Sleep Apnoea Using Prolonged Overnight Oximetry in an Unselected Population Referred to Secondary Care Reporting Excessive Daytime Sleepiness
- ClinicalTrials.gov ID
- NCT04287751
- Acronym / sponsor ID
- PROXIMO / 20/LO/0055
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnoea, Overnight Oximetry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Somerset NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obstructive sleep apnoea (OSA) is a common condition, effecting an estimated 1.5 million people in the UK and it is believed up to 80% of them may be undiagnosed [1]. During sleep the muscles supporting the upper airway tend to relax and the throat narrows. In patients with OSA the narrowing leads to collapse and pauses in breathing. These pauses in breathing are accompanied by a decrease in arterial oxygen saturation and to overcome the airway collapse the body responds by producing a surge in the sympathetic nervous system. This has the effect of stimulating the pharyngeal muscles to reopen the throat but also causes an increase in heart rate, blood pressure and disrupts the sleep cycle waking the patient up. These repeated disruptions to sleep leads to the patient feeling unrefreshed by sleep, excessively sleepy during the day and at increased risk of a sleepiness-related accident. The repetitive surges in the sympathetic nervous system also contributes to the risk of long term cardiovascular disease. The frequency with which these events occur determines the severity of obstructive sleep apnoea, less than 5 events per hour is considered normal, 5-15 mild, 15-30 moderate and more than 30 severe disease. However the disease severity does not correlate with the degree of symptoms [2] meaning it is important to identify patients even if they have mild and moderate disease.
OSA is effectively treated with continuous positive airway pressure (CPAP) therapy. These machines blow air into the throat through a nose or face mask. This helps to splint the airway open and reduce the disruption to sleep. CPAP is an effective therapy improving sleepiness, snoring, mood and reduces the long term risk of cardiovascular disease seen in untreated patients with OSA.
Full inpatient polysomnography testing is the gold standard investigation for diagnosis and exclusion of OSA [3]. However because polysomnography generally requires a hospital bed, significant technical input to set up and is time intensive to report it is impractical for the large numbers of patients referred to sleep services to undergo this test. Overnight oximetry recording has been established as an effective alternative for screening patients and identifying OSA in many sleep centres [4-6].
For a single test to be effective it needs to be highly sensitive and the condition being investigated should be stable. However significant variation in the severity of obstructive sleep apnoea has been demonstrated from night to night in individual patients [7, 8]. Therefore using oximetry or even polysomnography recording for a single night may not truly reflect the overall condition. Patients with mild and moderate disease show the most significant variations on a night to night basis, as the oxygen desaturation index (ODI, number of times the oxygen saturations dip per hour) rises, i.e. more severe OSA, less night to night variability is observed [9]. When patients with previously diagnosed OSA are withdrawn from CPAP treatment and overnight oximetry performed for two weeks only 22% of participants consistently remain within one severity category. The majority of these patients were in the severe category. Other studies have shown 40-50% of patients changing severity category in two to four nights recordings [7, 10] and that 16-20% of patients would not have received CPAP treatment based on a single night study but did so after repeating between one to three studies [10, 11].
The most clinically relevant distinction to make is between no OSA and mild and moderate OSA as this determines whether a trial of CPAP therapy would be offered. These previous trials suggest it is within this milder spectrum of the disease where a single night's oximetry recording is least reliable and more than one night's recording may be required.
Despite CPAP being a very successful treatment for OSA, adherence rates to treatment are variable [12, 13]. It has also be shown that adherence correlates with OSA severity [14]. In part this poor adherence to treatment suggests imperfect identification of patients. The investigators hypothesise that the current oximetry screening of a single night may not be effectively identifying all those patients who may benefit from CPAP. The investigators aim to identify how many additional patients are identified as having OSA with prolonged, multi-night recordings. A longer period of oximetry recording may improve the identification of those patients who may benefit from CPAP and may help to identify factors that predict a poorer response to CPAP therapy. Therefore this study will follow-up patients to see if those identified by prolonged oximetry screening tests leads to improved adherence to CPAP.
Two different oximeters are used in this study. The Minolta i300 was chosen as it is the current device used within the investigators clinical service. This is not being used for prolonged recordings as the battery life makes it impractical to be used for more than two nights recording. Therefore the CheckMeO2 oximeter was chosen; this has a rechargeable battery and sufficient memory capacity to be used for the required 4 nights of recording.
The CheckMe O2 device records oxygen saturations to nearest whole number every 4 seconds versus the Minolta device recording to one decimal place every second. It is felt that as the average length of a desaturation in obstructive sleep apnoea is 15-20 seconds the CheckMe O2 device should be sufficiently accurate to detect OSA but by performing a simultaneous recording during the first night the investigators hope to establish if this frequency of recording is sufficient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Recruiting participants undergoing overnight oximetry on a single night to have additional 4 nights of recording with a prolonged recording oximeter device
| Arm | Type | Receives |
|---|---|---|
| Overnight Oximetry | Other | Device: CheckMeO2 OximeterParticipants record simultaneously overnight oximetry on night 1 and continue with prolonged recordings alone for a total of 4 nights |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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'
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CheckMeO2 OximeterSimultaneous 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. | Device | Overnight Oximetry |
Primary outcome
Incidence of OSA on 1 night vs 4 nights Oximetry
Time frame: 4 days
To compare the incidence of OSA using current single night recording versus multiple night recordings
2 secondary outcomes
To compare the adherence rates to CPAP at 1 month follow-up
Time frame: 1 month
To assess the tolerability of prolonged oximetry screening for patients
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Individual participant dataSharing planned: No
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A Study of the Sleepnet Elara APAP Device
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Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
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EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Pepperell principal investigator
Somerset NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing CheckMeO2 Oximeter in people with Obstructive Sleep Apnea, run by Somerset NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Davidson, MBBCh (07867 408463, james.davidson@tst.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of OSA on 1 night vs 4 nights Oximetry (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020; AzTrials last refreshed its copy on 29 Oct 2026.