COPDNCT05857475
Efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome
A study testing CPAP therapy in people with COPD and OSA, run by Mahidol University at 1 site in Thailand.
Trial summary
To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, OSA, Lung Function Decreased
- What is being tested?
- CPAP therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2023to 1 Jan 2024
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis with COPD by GOLD guideline criteria (Post bronchodilator FEV1/FVC < 0.7 or < LLN) with post bronchodilator FEV1 = 30-80%
- Diagnosis with obstructive sleep apnea with AHI > 15 event/hr. (Moderate OSA or more)
- Age between 40-80 years
- Stable disease prior to inclusion.
Who cannot join
- Diagnosis with > 50% of central sleep apnea event
- History of COPD exacerbation during the past 8 week prior to inclusion.
- Subjects who cannot perform spirometry test or walking test
- Subjects with recording history of chronic heart failure, significant arrhythmias, acute myocardial infarction, moderate to severe mitral or aortic valve disease and pulmonary hypertension.
- Subjects with interstitial lung disease.
- Subjects with neuromuscular disease.
Show all 10Show fewer
- Subjects with morbid obesity (BMI >/=35)
- Subjects with chronic respiratory infection.
- Subjects with chronic CO2 retension (PaCO2 >/= 45 from arterial blood gas analysis) or Transcutaneous CO2 during sleep test >/= 45 or Serum bicarbonate level > 27
- Subjects with acute or active respiratory infecton during 2 week prior to inclusion.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, 10400
About this study
To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome
Read the detailed description
To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome by 6 minute walking distance and oxygen consumption.
- Conditions
- COPD, OSA, Lung Function Decreased
- Being tested
- CPAP therapy, Control
- Keywords
- COPD-OSA overlap syndrome, Pulmonary function test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP therapyDevice
Continous positive airway pressure therapy
ControlOther
No CPAP
| Study group | Role | What they receive |
|---|---|---|
| CPAP therapy | Experimental | CPAP therapy will be used in this arm for 2 month. Receives: Device: CPAP therapy |
| Control | Other | CPAP therapy will not be used in this arm for 2 month. (subject were assign to normal waiting list in order to borrowing hospital PAP machine.) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walking test distance
To measure distance subject could walk during the period of 6 minute
Measured: 2 months
Secondary outcomes (8)
Quality of life by questionaires: COPD Assessment Test (CAT)
Using COPD Assessment Test (CAT) questionaires to assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness, activities, confident, sleep and sleep) on health status
- Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life
Measured: 2 months
Quality of life by questionaires: modified British Medical Research Council Dyspnea Scale (mMRC)
Using COPD modified British Medical Research Council Dyspnea Scale (mMRC) to assess the degree of functional disability due to dyspnea.
Measured: 2 months
Quality of life by questionaires: St. George's Respiratory Questionnaire (SGRQ)
Using St. George's Respiratory Questionnaire (SGRQ) to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.
SGRQ is divided into 2 part
- Part I (Symptoms): several scales.
- Part II (Activity and Impacts): dichotomous (true/false). Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: 2 months
Quality of life by Sleep quality questionaires: Pittsburgh Sleep Quality Index (PSQI)
Using Pittsburgh Sleep Quality Index (PSQI) to assesses adult patients' sleep quality and disturbances over one month with question about Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: 2 months
Quality of life by Sleep quality questionaires: Functional Outcomes of Sleep Questionnaire (FOSQ)
Using Functional Outcomes of Sleep Questionnaire (FOSQ) to to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment.
The questionaire ask about activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty)
Measured: 2 months
Quality of life by Sleep quality questionaires: Epworth Sleepiness Scale (ESS)
Using Epworth Sleepiness Scale (ESS) to measure sleepiness in daily life. The ESS asks the patient to rate their likelihood of falling asleep under 8 different circumstances.
Measured: 2 months
Quality of life by Sleep quality questionaires: Lausanne NoSAS (Neck circumference, Obesity, Snoring, Age, Sex) score
Using Lausanne NoSAS (Neck circumference, Obesity, Snoring, Age, Sex) score to guide identification of individuals at risk of sleep-disordered breathing
Measured: 2 months
Aerobic capacity
Measure oxygen consumption during performing 6 minute walking test
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To compare pulmonary function of COPD-OSA overlap subjects who using and not using (waiting list for PAP therapy) in the period of 2 months.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857475
- Sponsor's protocol ID
- MahidolU 4564
- Status last verified
- Feb 2024
- First submitted
- 3 Mar 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome
- ClinicalTrials.gov ID
- NCT05857475
- Acronym / sponsor ID
- MahidolU 4564
- Conditions
- COPD, OSA, Lung Function Decreased
- Keywords
- COPD-OSA overlap syndrome, Pulmonary function test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 12 May 2023 (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.
To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome
Detailed description
To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome by 6 minute walking distance and oxygen consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To compare pulmonary function of COPD-OSA overlap subjects who using and not using (waiting list for PAP therapy) in the period of 2 months.
| Arm | Type | Receives |
|---|---|---|
| CPAP therapy | Experimental | Device: CPAP therapyCPAP therapy will be used in this arm for 2 month. |
| Control | Other | Other: ControlCPAP therapy will not be used in this arm for 2 month. (subject were assign to normal waiting list in order to borrowing hospital PAP machine.) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis with COPD by GOLD guideline criteria (Post bronchodilator FEV1/FVC < 0.7 or < LLN) with post bronchodilator FEV1 = 30-80%
- Diagnosis with obstructive sleep apnea with AHI > 15 event/hr. (Moderate OSA or more)
- Age between 40-80 years
- Stable disease prior to inclusion.
Key exclusion criteria (10 listed)
- Diagnosis with > 50% of central sleep apnea event
- History of COPD exacerbation during the past 8 week prior to inclusion.
- Subjects who cannot perform spirometry test or walking test
- Subjects with recording history of chronic heart failure, significant arrhythmias, acute myocardial infarction, moderate to severe mitral or aortic valve disease and pulmonary hypertension.
- Subjects with interstitial lung disease.
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 |
|---|---|---|
| CPAP therapyContinous positive airway pressure therapy | Device | CPAP therapy |
| ControlNo CPAP | Other | Control |
Primary outcome
6 minute walking test distance
Time frame: 2 months
To measure distance subject could walk during the period of 6 minute
8 secondary outcomes
Quality of life by questionaires: COPD Assessment Test (CAT)
Time frame: 2 months
Quality of life by questionaires: modified British Medical Research Council Dyspnea Scale (mMRC)
Time frame: 2 months
Quality of life by questionaires: St. George's Respiratory Questionnaire (SGRQ)
Time frame: 2 months
Quality of life by Sleep quality questionaires: Pittsburgh Sleep Quality Index (PSQI)
Time frame: 2 months
Quality of life by Sleep quality questionaires: Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: 2 months
Quality of life by Sleep quality questionaires: Epworth Sleepiness Scale (ESS)
Time frame: 2 months
Quality of life by Sleep quality questionaires: Lausanne NoSAS (Neck circumference, Obesity, Snoring, Age, Sex) score
Time frame: 2 months
Aerobic capacity
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP therapy in people with COPD and OSA, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 5 Feb 2024. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
6 minute walking test distance (time frame: 2 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 5 Feb 2024.