Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome

SARS-CoV2 Infection Clinical Trial

Official title:

Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05116657
• Other study ID #: 21-031
• Status: Not yet recruiting
• Start date: November 22, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: November 2021
• Source: Royal College of Surgeons, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptoms of sleepiness, fatigue, loud snoring

Exclusion Criteria:

1. Gross skeletal alterations affecting the upper airway (eg.micrognathia)

2. Unstable chronic medical conditions known to affect OSA (CHF, stroke) 3.

3. Pregnancy or intent to become pregnant within the period of the protocol

4. Inability to sign informed consent form

5. Habitual snorer or previous diagnosis of OSA.

6. Less than 18 years of age.

Related Conditions & MeSH terms

• COVID-19
• Fatigue Syndrome, Chronic
• SARS-CoV2 Infection
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleepiness
• Snoring

Intervention

Diagnostic Test:
• Nasal Lavage and Oral Wash
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine the incidence of post SARS-CoV-2 infection obstructive sleep apnoea (OSA) and its relationships with the upper airway/nasal microenvironment		1 year
Secondary	Determine the relationship between post- SARS-CoV-2 Infection OSA, Positive Airway Pressure (PAP) treatment adherence and change in the upper airway/nasal microenvironment.		1 year