Obstructive Sleep ApneaPETSOCSSNCT05432102
Patient Experience and Technical Success of Community Sleep Studies
An observational study of Obstructive Sleep Apnea, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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… 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?
- Pulse oxymetry and Respiratory polygraphy
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 May 2022to Jul 2022
- Phase
- Observational
- 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
Study population: Patients undergoing a home sleep study at Royal Papworth Hospital
Who may be able to join
- Patient able to provide assent by completion of the Research Questionnaire Adult patients (≥ 18 years of age) Patients undergoing a home sleep study
Who cannot join
- Patients unable to complete questionnaires due to language or other barriers
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge
Earl Palas, +44 1223 638410, earl.palas@nhs.net
About this study
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.
Read the 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
- Being tested
- Pulse oxymetry, Respiratory polygraphy
- 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.
Pulse oxymetryDiagnostic test
Diagnostic intervention to diagnose OSA.
Respiratory polygraphyDiagnostic test
Diagnostic intervention to diagnose OSA.
| Study group | Role | What they receive |
|---|---|---|
| Participants having respiratory polygraphy | This label will used to describe participants having respiratory polygraphy at Royal Papworth Hospital over a 3 month period. Receives: Diagnostic Test: Respiratory polygraphy | |
| Participants having pulse oximetry | This label will used to describe participants having pulse oximetry at Royal Papworth Hospital over a 3 month period. Receives: Diagnostic Test: Pulse oxymetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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?
Measured: 3 months
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?
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start4 May 2022
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Iceni Laboratories, CRN Eastern
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432102
- Sponsor's protocol ID
- P02530
- Acronym
- PETSOCSS
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Experience and Technical Success of Community Sleep Studies
- ClinicalTrials.gov ID
- NCT05432102
- Acronym / sponsor ID
- PETSOCSS / P02530
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- Iceni Laboratories, CRN Eastern
- Study start
- 4 May 2022 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 27 Jun 2022 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants having respiratory polygraphy | – | Diagnostic Test: Respiratory polygraphyThis label will used to describe participants having respiratory polygraphy at Royal Papworth Hospital over a 3 month period. |
| Participants having pulse oximetry | – | Diagnostic Test: Pulse oxymetryThis label will used to describe participants having pulse oximetry at Royal Papworth Hospital over a 3 month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a home sleep study at Royal Papworth Hospital
Key inclusion criteria (1 listed)
- Patient able to provide assent by completion of the Research Questionnaire Adult patients (≥ 18 years of age) Patients undergoing a home sleep study
Key exclusion criteria (1 listed)
- Patients unable to complete questionnaires due to language or other barriers
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 |
|---|---|---|
| Pulse oxymetryDiagnostic intervention to diagnose OSA. | Diagnostic test | Participants having pulse oximetry |
| Respiratory polygraphyDiagnostic intervention to diagnose OSA. | Diagnostic test | Participants having respiratory polygraphy |
Primary outcome
Satisfactory sleep studies
Time frame: 3 months
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.
2 secondary outcomes
Extent of sleep disruption
Time frame: 3 months
Extent of signal failure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Katharine Woodall (+44 1223 639636, katharine.woodall@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfactory sleep studies (time frame: 3 months). 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 Jun 2022.