The Efficacy of Continuous Positive Airway Pressure in Achieving Asthma Control in Patients With Severe Asthma and Obstructive Sleep Apnea

NCT05470153 | Unknown DMC

• 1 other identifier: 269-20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a common heterogeneous chronic disorder of the airways, characterized by variables, usually reversible and recurring symptoms related to one or more of airflow obstruction, bronchial hyper-responsiveness, and underlying inflammation. Approximately 5-10% of asthmatics have severe or difficult to treat asthma that remains problematic despite optimal treatment. Current asthma guideline recommend investigating the presence of OSA in the cases of severe or uncontrolled asthma. Obstructive sleep apnea (OSA) is a disease that characterized by frequent narrowing or collapsed of upper airways during sleep. Recent studies have shown an overlap between Asthma and Obstructive Sleep Apnea. The mechanism of interaction between OSA and asthma is complex. Moreover, the two diseases have common comorbid conditions such as GERD and obesity which negatively impact asthma control. Polysomnography is the study of sleep using different leads, heart rate and oxygen monitor to assess the architecture of the sleep. Abnormal obstructive breathing events during monitored sleep are described according to the latest recommendation of the American Academy of Sleep Medicine. For each patient with OSA, titration of CPAP pressure will be performed by conventional polysomnography or using auto-CPAP equipment using a validated protocol. The investigators aim in this study to examine the effect of CPAP treatment in severe asthma patient with concurrent moderate and severe OSA.

Conditions

Severe Asthma With Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• Determine the effect of Continuous Positive Air Pressure treatment in severe asthma patient with concurrent moderate and severe Obstructive Sleep Apnea

  Epworth Sleepiness Scale : a questionnaire of 8 questions about the degree of sleepiness in different situations. Which then they grade the degree from (0)Never, (1)Slight chance, (2)Moderate chance, (3)High chance after addition of score. The results will be interpreted as follows: a score from 0-5 : considered as lower normal daytime sleepiness a score from 6-10 : considered as normal daytime sleepiness a score from 11-12 : considered as mild excessive daytime sleepiness a score from 13-15 : considered as moderate daytime sleepiness a score from 16-24 : considered as severe excessive daytime sleepiness The higher the score the higher chances for the patient to have excessive daytime sleepiness

  6 months

• Asthma Control Test (ACT)

  contains 5 questions to assess the severity of the asthma symptoms in the last 4 weeks The results range from 5 (poor control of asthma), with a higher score 25 (complete control of asthma). The higher the score reflects on better control of asthma symptoms.

  6 months

• Asthma Symptoms Control (GINA Assessment of Asthma Control)

  consists of 4 Yes or No questions regarding asthma symptoms in the last 4 weeks. to determine the level of asthma symptom control. interpretation of the result is read as: * Well controlled (none of the above) * Partly controlled (1-2 yes to the questions) * Uncontrolled (3-4 yes to the questions)

  6 months

Study Arms (3)

Asthma with Obstructive Sleep Apnea on treatment

ACTIVE COMPARATOR

Over the following 6 months of recruiting the study population with severe asthma the following will be monitored EVERY MONTH: Level of asthma control: Asthma Control Test/GINA guidelines Excessive Daytime Sleepiness using Epworth Sleepiness Scale. Rate of exacerbations/hospitalization Continuous Positive Airway Pressure (CPAP) compliance: where acceptable compliance is defined as minimum of CPAP use of \>/= 4 hrs/70% nights (if applicable), In one month, 3month, 6 month duration Apnea/Hypopnea Index as per CPAP reading (if applicable)

Device: Continuous Positive Airway Pressure

Asthma with Obstructive Sleep Apnea whom refused treatment

NO INTERVENTION

Over the following 6 months of recruiting the study population with severe asthma the following will be monitored EVERY MONTH: Level of asthma control: Asthma Control Test/GINA guidelines Excessive Daytime Sleepiness using Epworth Sleepiness Scale. Rate of exacerbations/hospitalization

Asthma without Obstructive Sleep Apnea

NO INTERVENTION

Over the following 6 months of recruiting the study population with severe asthma the following will be monitored EVERY MONTH: Level of asthma control: Asthma Control Test/GINA guidelines Excessive Daytime Sleepiness using Epworth Sleepiness Scale. Rate of exacerbations/hospitalization

Interventions

Continuous Positive Airway Pressure DEVICE

For each patient with Obstructive Sleep Apnea, titration of Continuous Positive Airway Pressure (CPAP) pressure will be performed by conventional polysomnography or using auto-CPAP equipment using a validated protocol. The CPAP device should have an hour meter recording system, so that machine-on time hours could be checked at each clinical visit.

Asthma with Obstructive Sleep Apnea on treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The diagnosis of asthma and the classification of disease severity will be established according to the Global Initiative for Asthma (GINA) criteria. Asthma diagnosis is based either on spirometry that shows an obstructive airway defect with reversibility that has been defined as a minimum of 12% increase in the post-bronchodilator forced expiratory volume in 1 s (FEV1) and \>200 mL of the FEV1, or subjects with physician-diagnosed asthma.
• Severe Asthma (defined as being on step 4 or 5 of treatment as per GINA guidelines 2019)
• All patients should not change their controller therapy for at least eight weeks before enrollment to participate in the study.
• All patients should be naïve to CPAP.

You may not qualify if:

• Mild or Moderate asthma according on GINA 2019
• Patients with cardiac diseases, other lung diseases (Such as COPD and restrictive lung disease), cognitive impairment that could limit the comprehension or collaboration of the subject in the study, or any severe decompensated comorbid disease
• Patients with acute asthma exacerbation within 4 weeks of recruitment
• Pregnancy
• Smoker

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University Hospital

Jeddah, Western, 22230, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Siraj O Wali, Professor

CONTACT

0126408222; sowali@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Sleep Medicine and Research Center, Professor of Medicine

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: April 1, 2021
• Primary Completion: March 30, 2023
• Study Completion: May 30, 2023
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)