SleepinessNCT05116657
Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome
An observational study of Sleepiness and SARS-CoV2 Infection, run by Royal College of Surgeons, Ireland.
Trial summary
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) causing coronavirus disease, Covid-19, has spread rapidly across the globe since its emergence in January 2020. As of January 2021, there are 87.6 million confirmed cases worldwide, with 1.9milion deaths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleepiness, SARS-CoV2 Infection, Fatigue Syndrome, Chronic
- What is being tested?
- Nasal Lavage and Oral Wash
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 22 Nov 2021to 1 Jan 2023
- 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: Participants will be selected from the Sleep Clinic and Post-Covid Clinic in Beaumont Hospital. Participants with snoring and daytime somnolence requiring sleep assessment as part of routine clinical care will be selected.
Who may be able to join
- Symptoms of sleepiness, fatigue, loud snoring
Who cannot join
- Gross skeletal alterations affecting the upper airway (eg.micrognathia)
- Unstable chronic medical conditions known to affect OSA (CHF, stroke) 3.
- Pregnancy or intent to become pregnant within the period of the protocol
- Inability to sign informed consent form
- Habitual snorer or previous diagnosis of OSA.
- Less than 18 years of age.
About this study
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) causing coronavirus disease, Covid-19, has spread rapidly across the globe since its emergence in January 2020. As of January 2021, there are 87.6 million confirmed cases worldwide, with 1.9milion deaths. In conjunction with this high disease incidence, there have also been reports of Covid-19 related sleep disordered breathing, with up 18% in a Chinese study and 57% in an Italian study of individuals with Covid-19 reporting sleep disturbance.
Obstructive Sleep Apnea (OSA) is a common, chronic condition due to partial or complete upper airway collapse during sleep. OSA is more common in males \& obese individuals, both of which are more adversely affected by SARS-CoV-2 infection. Furthermore, inflammation of the upper airway, or nasal passages leading to congestion could lead to a compromised upper airway during sleep and subsequently, obstructive sleep apnea.
Read more
We believe that's SARS -CoV-2 infection, and subsequent Covid-19 will lead to an altered microbiome in the upper airway. This is turn will lead to worsening nasal inflammation and congestion, which could predispose individual with previous Covid-19 disease to OSA.
Additionally, OSA is treated with Continuous Positive Airway Pressure (CPAP) a machine which delivers pressurized air into the upper airway via a face mask. This keeps the upper airway open during sleep. When CPAP is well tolerated by individuals, it works well to reduce the symptoms of OSA. Unfortunately, many patients find it difficult to tolerate CPAP. One reason often reported for poor tolerance is nasal congestion. We believe that an altered upper airway microbiome, due to previous SARS-CoV-2 infection, will affect treatment adherence to CPAP therapy. Secondly, we will investigate if treatment with CPAP therapy causes any change in the upper airway microbiome.
- Conditions
- Sleepiness, SARS-CoV2 Infection, Fatigue Syndrome, Chronic, Snoring
- Being tested
- Nasal Lavage and Oral Wash
- Keywords
- sars-CoV2, microbiome, obstructive sleep apnea
- Medical subject headings
- Sleepiness, COVID-19, Fatigue Syndrome, Chronic, Snoring, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Lavage and Oral WashDiagnostic test
Also called Home Sleep Study, Positive Airway Pressure if diagnosed with Sleep Apnea
- Nasal Lavage: The nasal lavage will be performed using a spray technique. Using a disposable metered-dose inhaler (100 µl per spray), room temperature saline will be sprayed in one nostril while the other nostril is closed. After 5 sprays, the subject will gently exhale through the lavaged nostril and the fluid will be collected in a specimen cup. The procedure will be repeated a minimum of 8 times and a maximum of 15 times in each nostril. After collection, the sample will be placed on ice and processed within 2 hours.
- Oral Rinse: Oral samples will be collected using a standardized procedure in accordance with the Manual of Procedures for Human Microbiome Project.Study participants will rinse their mouth (swish/gargle) with 15 mL sterile normal saline for 1 min, and will expectorate the contents of the mouth into a 50 mL centrifuge tube. Sample should be kept cold on ice until processing.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV2 OSA | Patients will be recruited from both Post-COVID19 and Sleep Clinics run through Beaumont Hospital, Beaumont, Dublin, Ireland. This will allow for the recruitment of patients with and without a history of SARS-CoV-2 infection. Receives: Diagnostic Test: Nasal Lavage and Oral Wash | |
| Non-SARS-CoV2 OSA | Patients will be recruited from both Post-COVID19 and Sleep Clinics run through Beaumont Hospital, Beaumont, Dublin, Ireland. This will allow for the recruitment of patients with and without a history of SARS-CoV-2 infection. Receives: Diagnostic Test: Nasal Lavage and Oral Wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the incidence of post SARS-CoV-2 infection obstructive sleep apnoea (OSA) and its relationships with the upper airway/nasal microenvironment
Measured: 1 year
Secondary outcomes (1)
Determine the relationship between post- SARS-CoV-2 Infection OSA, Positive Airway Pressure (PAP) treatment adherence and change in the upper airway/nasal microenvironment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start22 Nov 2021 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepinessStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116657
- Sponsor's protocol ID
- 21-031
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 11 Nov 2021
- 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 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome
- ClinicalTrials.gov ID
- NCT05116657
- Acronym / sponsor ID
- 21-031
- Conditions
- Sleepiness, SARS-CoV2 Infection, Fatigue Syndrome, Chronic, Snoring
- Keywords
- sars-CoV2, microbiome, obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 22 Nov 2021 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 11 Nov 2021 (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.
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) causing coronavirus disease, Covid-19, has spread rapidly across the globe since its emergence in January 2020. As of January 2021, there are 87.6 million confirmed cases worldwide, with 1.9milion deaths. In conjunction with this high disease incidence, there have also been reports of Covid-19 related sleep disordered breathing, with up 18% in a Chinese study and 57% in an Italian study of individuals with Covid-19 reporting sleep disturbance.
Obstructive Sleep Apnea (OSA) is a common, chronic condition due to partial or complete upper airway collapse during sleep. OSA is more common in males \& obese individuals, both of which are more adversely affected by SARS-CoV-2 infection. Furthermore, inflammation of the upper airway, or nasal passages leading to congestion could lead to a compromised upper airway during sleep and subsequently, obstructive sleep apnea.
We believe that's SARS -CoV-2 infection, and subsequent Covid-19 will lead to an altered microbiome in the upper airway. This is turn will lead to worsening nasal inflammation and congestion, which could predispose individual with previous Covid-19 disease to OSA.
Additionally, OSA is treated with Continuous Positive Airway Pressure (CPAP) a machine which delivers pressurized air into the upper airway via a face mask. This keeps the upper airway open during sleep. When CPAP is well tolerated by individuals, it works well to reduce the symptoms of OSA. Unfortunately, many patients find it difficult to tolerate CPAP. One reason often reported for poor tolerance is nasal congestion. We believe that an altered upper airway microbiome, due to previous SARS-CoV-2 infection, will affect treatment adherence to CPAP therapy. Secondly, we will investigate if treatment with CPAP therapy causes any change in the upper airway microbiome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV2 OSA | – | Diagnostic Test: Nasal Lavage and Oral WashPatients will be recruited from both Post-COVID19 and Sleep Clinics run through Beaumont Hospital, Beaumont, Dublin, Ireland. This will allow for the recruitment of patients with and without a history of SARS-CoV-2 infection. |
| Non-SARS-CoV2 OSA | – | Diagnostic Test: Nasal Lavage and Oral WashPatients will be recruited from both Post-COVID19 and Sleep Clinics run through Beaumont Hospital, Beaumont, Dublin, Ireland. This will allow for the recruitment of patients with and without a history of SARS-CoV-2 infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from the Sleep Clinic and Post-Covid Clinic in Beaumont Hospital. Participants with snoring and daytime somnolence requiring sleep assessment as part of routine clinical care will be selected.
Key inclusion criteria (1 listed)
- Symptoms of sleepiness, fatigue, loud snoring
Key exclusion criteria (6 listed)
- Gross skeletal alterations affecting the upper airway (eg.micrognathia)
- Unstable chronic medical conditions known to affect OSA (CHF, stroke) 3.
- Pregnancy or intent to become pregnant within the period of the protocol
- Inability to sign informed consent form
- Habitual snorer or previous diagnosis of OSA.
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 |
|---|---|---|
| Nasal Lavage and Oral WashAlso: Home Sleep Study, Positive Airway Pressure if diagnosed with Sleep Apnea* Nasal Lavage: The nasal lavage will be performed using a spray technique. Using a disposable metered-dose inhaler (100 µl per spray), room temperature saline will be sprayed in one nostril while the other nostril is closed. After 5 sprays, the subject will gently exhale through the lavaged nostril and the fluid will be collected in a specimen cup. The procedure will be repeated a minimum of 8 times and a maximum of 15 times in each nostril. After collection, the sample will be placed on ice and processed within 2 hours. * Oral Rinse: Oral samples will be collected using a standardized procedure in accordance with the Manual of Procedures for Human Microbiome Project.Study participants will rinse their mouth (swish/gargle) with 15 mL sterile normal saline for 1 min, and will expectorate the contents of the mouth into a 50 mL centrifuge tube. Sample should be kept cold on ice until processing. | Diagnostic test | Non-SARS-CoV2 OSA, SARS-CoV2 OSA |
Primary outcome
Examine the incidence of post SARS-CoV-2 infection obstructive sleep apnoea (OSA) and its relationships with the upper airway/nasal microenvironment
Time frame: 1 year
1 secondary outcome
Determine the relationship between post- SARS-CoV-2 Infection OSA, Positive Airway Pressure (PAP) treatment adherence and change in the upper airway/nasal microenvironment.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleepiness and SARS-CoV2 Infection, run by Royal College of Surgeons, Ireland.
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 6 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 11 Nov 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine the incidence of post SARS-CoV-2 infection obstructive sleep apnoea (OSA) and its relationships with the upper airway/nasal microenvironment (time frame: 1 year). 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 11 Nov 2021.