Pulmonary Disease, Chronic ObstructiveEDIN-IDINNCT06713486
Efficacy of Self-titration of Ventilation in Overlap Syndrome (chronic Obstructive Pulmonar Disease + Sleep Apnea Syndrome ) with Dynamic Hyperinflation. EDIN-IDIN.
A study testing Fixed pressure obtained in the polysomnography for 28 days and Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode in people with Pulmonary Disease, Chronic Obstructive, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
The combination of COPD and obstructive sleep apnea (OSA) can lead to undesirable interactions with the treatment approach. The investigators know that continuous positive airway pressure (CPAP) can increase dynamic hyperinflation in COPD patients, and in mechanical ventilation, the increase in PEEP can worsen dynamic… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Fixed pressure obtained in the polysomnography for 28 days and Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stability of at least 4 weeks without hospital admission.
- Previously presented PCO2 > 52.
- Age between 50 and 80 years.
- Agree to participate in the study and sign the informed consent.
- Both sexes.
Who cannot join
- Refusal to participate in the study.
- Uncontrolled structural or coronary heart disease (no changes in medication in the last 15 days).
- LVEF < 45%.
- Central sleep apnea syndrome (≥ 50% central events).
- Uncontrolled pulmonary hypertension.
- Inability to perform the tests.
Show all 12Show fewer
- Having had an exacerbation 4 weeks prior.
- Severe psychiatric illness.
- Cognitive impairment.
- Not speaking Spanish.
- Illiteracy.
- Active smoker (or < 6 months since quitting smoking).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Herminia Buchelli Ramirez Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD contact
Francisco José Ruiz López Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD contact
Spain1 site
Servicio de Neumología. Hospital Universitario Virgen de la Arrixaca.
Murcia, Murcia, 30120
Francisco José Ruiz López Ruiz Lopez, MD, 968369500 ext. Exts 369422/36, fjose.ruiz1@um.es
Francisco José Ruiz López Ruiz Lopez, MD
About this study
The combination of COPD and obstructive sleep apnea (OSA) can lead to undesirable interactions with the treatment approach. The investigators know that continuous positive airway pressure (CPAP) can increase dynamic hyperinflation in COPD patients, and in mechanical ventilation, the increase in PEEP can worsen dynamic hyperinflation. On the other hand, the team know that the severity of COPD obstruction and hyperinflation alter sleep efficiency, with periods of wakefulness during sleep, and during these periods, the patient would not have upper airway obstruction, which could affect the therapy they are receiving in CPAP mode for OSA. Moreover, it was observed that with greater hyperinflation, the rate of obstructive events decreases, dynamically affecting the ventilatory situation with upper airway resistance. Recent studies have determined the safety and efficacy of auto-adjusting systems in the treatment of overlap syndrome, which could be more adaptable to the changing pulmonary mechanics of these patients. Aerobic capacity is a good predictor to the health status in these patients and the investigators know it is reduced in patients with AOS, where CPAP treatment according to studies improves the peak VO2. Therefore, the objective is to compare a ventilation system with fixed pressures established through polysomnography in patients with overlap syndrome and dynamic hyperinflation to a dynamic ventilation system using the fixed pressure limits typically established, based on their impact on the aerobic capacity (peak VO2) of these patients after 1 month of treatment.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Fixed pressure obtained in the polysomnography for 28 days, Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed pressure obtained in the polysomnography for 28 daysProcedure or surgery
home nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days
Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® modeProcedure or surgery
dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode (program B) for 28 days, using the apnea threshold obtained in the titration as the maximum EPAP pressure and adjusting the support pressure for inferred Vt to 8 ml/kg of ideal body weight. After the first 28 days, a polysomnography will be performed under therapy with the device, and the next morning, cycle ergometry will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| FIXED PRESSURE | Experimental | Home nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days Receives: Procedure: Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode |
| B | Active comparator | Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode for 28 days. Receives: Procedure: Fixed pressure obtained in the polysomnography for 28 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak VO2
Peak VO2 as the primary variable obtained from cycle ergometry.
Measured: 0,29 and 57 days.
Secondary outcomes (7)
VO2 max
VO2 max as a secondary variable obtained from cycle ergometry
Measured: 0,29 and 57 days.
Anaerobic threshold
Anaerobic threshold as a secondary variable obtained from cycle ergometry.
Measured: 0,29 and 57 days.
VE/VCO2
The slope of VE/VCO2 obtained from cycle ergometry and resting PEtCO2.
Measured: 0,29 and 57 days.
BODE INDEX. (body mass index,)
Polysomnography
Measured: 0,29 and 57 days.
BODE INDEX. ( air-flow obstruction)
Time in hypoventilation period both during wakefulness and sleep, and as a function of total sleep time.
Measured: 0,29 and 57 days.
BODE INDEX. (dyspnea, )
number of residual respiratory events, time in hypoventilation period both during wakefulness and sleep, and as a function of total sleep time.
Measured: 0,29 and 57 days.
BODE INDEX. (exercise capacity)
Measured: 0,29 and 57 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713486
- Sponsor's protocol ID
- EDIN-IDIN
- Acronym
- EDIN-IDIN
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 3 Dec 2024
- 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 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Self-titration of Ventilation in Overlap Syndrome (chronic Obstructive Pulmonar Disease + Sleep Apnea Syndrome ) with Dynamic Hyperinflation. EDIN-IDIN.
- ClinicalTrials.gov ID
- NCT06713486
- Acronym / sponsor ID
- EDIN-IDIN / EDIN-IDIN
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 3 Dec 2024 (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.
The combination of COPD and obstructive sleep apnea (OSA) can lead to undesirable interactions with the treatment approach. The investigators know that continuous positive airway pressure (CPAP) can increase dynamic hyperinflation in COPD patients, and in mechanical ventilation, the increase in PEEP can worsen dynamic hyperinflation. On the other hand, the team know that the severity of COPD obstruction and hyperinflation alter sleep efficiency, with periods of wakefulness during sleep, and during these periods, the patient would not have upper airway obstruction, which could affect the therapy they are receiving in CPAP mode for OSA. Moreover, it was observed that with greater hyperinflation, the rate of obstructive events decreases, dynamically affecting the ventilatory situation with upper airway resistance. Recent studies have determined the safety and efficacy of auto-adjusting systems in the treatment of overlap syndrome, which could be more adaptable to the changing pulmonary mechanics of these patients. Aerobic capacity is a good predictor to the health status in these patients and the investigators know it is reduced in patients with AOS, where CPAP treatment according to studies improves the peak VO2. Therefore, the objective is to compare a ventilation system with fixed pressures established through polysomnography in patients with overlap syndrome and dynamic hyperinflation to a dynamic ventilation system using the fixed pressure limits typically established, based on their impact on the aerobic capacity (peak VO2) of these patients after 1 month of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIXED PRESSURE | Experimental | Procedure: Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® modeHome nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days |
| B | Active comparator | Procedure: Fixed pressure obtained in the polysomnography for 28 daysDynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode for 28 days. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stability of at least 4 weeks without hospital admission.
- Previously presented PCO2 > 52.
- Age between 50 and 80 years.
- Agree to participate in the study and sign the informed consent.
- Both sexes.
Key exclusion criteria (12 listed)
- Refusal to participate in the study.
- Uncontrolled structural or coronary heart disease (no changes in medication in the last 15 days).
- LVEF < 45%.
- Central sleep apnea syndrome (≥ 50% central events).
- Uncontrolled pulmonary hypertension.
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 |
|---|---|---|
| Fixed pressure obtained in the polysomnography for 28 dayshome nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days | Procedure or surgery | B |
| Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® modedynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode (program B) for 28 days, using the apnea threshold obtained in the titration as the maximum EPAP pressure and adjusting the support pressure for inferred Vt to 8 ml/kg of ideal body weight. After the first 28 days, a polysomnography will be performed under therapy with the device, and the next morning, cycle ergometry will be conducted. | Procedure or surgery | FIXED PRESSURE |
Primary outcome
Peak VO2
Time frame: 0,29 and 57 days.
Peak VO2 as the primary variable obtained from cycle ergometry.
7 secondary outcomes
VO2 max
Time frame: 0,29 and 57 days.
Anaerobic threshold
Time frame: 0,29 and 57 days.
VE/VCO2
Time frame: 0,29 and 57 days.
BODE INDEX. (body mass index,)
Time frame: 0,29 and 57 days.
BODE INDEX. ( air-flow obstruction)
Time frame: 0,29 and 57 days.
BODE INDEX. (dyspnea, )
Time frame: 0,29 and 57 days.
BODE INDEX. (exercise capacity)
Time frame: 0,29 and 57 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- 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.
Herminia Buchelli Ramirez Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD contact
Francisco José Ruiz López Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed pressure obtained in the polysomnography for 28 days and Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode in people with Pulmonary Disease, Chronic Obstructive, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 3 Dec 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Herminia Buchelli Ramirez Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD (TFL: 968369500. ext. Exts 369422/36, fjose.ruiz1@um.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak VO2 (time frame: 0,29 and 57 days.). 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 3 Dec 2024.