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Asthma and obstructive sleep apnea

Asthma and obstructive sleep apnea. The association, physiological inter-relation and impact of therapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12504088
Enrollment
40
Registered
2016-10-21
Start date
2016-11-01
Completion date
Unknown
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma and obstructive sleep apnea (OSA) Respiratory

Interventions

This study aims to examine various postulated physiological links between asthma and obstructive sleep apnea. There will be four groups of participant recruited from Respiratory and S

Sponsors

The Newcastle Upon Tyne Hospitals NHS Foundation Trusts.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Control group: 1.1. Normal males or females, who are 18 years or older. 1.2. No asthma on spirometry and no bronchodilator reversibility. 1.3. No OSA on sleep study and 1.4. No other known significant clinical condition according to the clinical assessment of Dr West/Dr Burns 2. OSA group: 2.1. Males or females, who are 18 years or older. 2.2. Significant OSA on sleep study, 2.3. having empirical CPAP clinically, 2.4. no asthma on spirometry and no bronchodilator reversibility. 2.5. No other known significant clinical condition according to the clinical assessment of Dr. West/Dr. Burns 3. Asthma group: 3.1. Males or females, who are 18 years or older who have a hospital corroborated clinical diagnosis of asthma. 4. Asthma with OSA group: 4.1. Males or females, who are 18 years or older 4.2. Confirmed asthma and confirmed OSA Definitions: 1. “No asthma” means: no history of asthma, normal spirometry and no bronchodilator response 2. “Asthma” means: hospital specialist respiratory physician diagnosis, with history consistent with asthma, previous obstructive spirometry, ratio 10 per hour or AHI of >15 per hour on overnight sleep study

Exclusion criteria

Exclusion criteria: For all groups 1. Inability to give written informed consent in English. 2. Where a participant is already involved in other research studies or medical intervention, which might have contraindications for this study. 3. Patients regarded unfit for any other clinical reason by their respiratory or sleep physician 4. As the study involve the use of a Pulmonary Function Test (PFT), some individuals with certain conditions should not take a PFT, as it can cause problems. These conditions include: 4.1. Recent heart attack 4.2. Heart disease 4.3. Recent eye surgery 4.4. Recent chest or abdominal surgery 4.5. Respiratory infections

Design outcomes

Primary

MeasureTime frame
1. The number of patients who were eligible for the study 2. The number invited to take part in the study 3. The number that entered the study 4. The number that completed the study 5. The number of patients where all observations were obtained This information is obtained and updated at each study visit up to the end of the study.

Secondary

MeasureTime frame
1. Change in Forced Expiratory Flow 25-75 (FEF 25-75) , Specific Airway Conductance (SGaW) post 1 hour Continuous Positive Airway Pressure (CPAP) in the patient groups. Spirometry done by body plethysmography is used to calculate FEF 25-75 and SGaW. • CPAP is administered by Resmed AirSense CPAP machine. Outcomes will be measured before and after 1 hour treatment with Continuous Positive Airway Pressure (CPAP) for all participants. 2. Change in Forced Expiratory Flow 25-75 (FEF 25-75), Specific Airway Conductance (SGaW) after one month treatment with Continuous Positive Airway Pressure (CPAP) in patients receiving CPAP. Spirometry done by body plethysmography is used to calculate FEF 25-75 and SGaW. • CPAP is done by Resmed AirSense CPAP machine. Outcomes will be measured before and after 1 month treatment with Continuous Positive Airway Pressure (CPAP) for patients who will have home CPAP (i.e., patients with Obstructive Sleep Apnea (OSA) with and without asthma). 3. The prevalence of reflux; salivary pepsin, Reflux Symptom Index (RSI) questionnaire and cough (Leicester cough questionnaire) in the patient groups. • Salivary pepsin is measured by a PEPTEST (a lateral flow, near patient measurement device that measures salivary pepsin). • Reflux Symptom Index is measured by the Reflux Symptom Index questionnaire. Cough is measured by the Leicester cough questionnaire. Outcomes will be measured at recruitment for all participants. For patients who have home CPAP (i.e. patients with Obstructive Sleep Apnea (OSA) with and without asthma). Outcomes will be measured after 1 month treatment with Continuous Positive Airway Pressure (CPAP) 4. Difference in Small airway function Forced Expiratory Flow 25-75 (FEF 25-75 (Specific Airway Conductance (SGaW) between the patient groups. Spirometry done by body plethysmography is used to calculate FEF 25-75 and SGaW. Outcomes will be measured at recruitments and after 1 hour Conti

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026