Efficacy of Self-titration of Ventilation in Overlap Syndrome (chronic Obstructive Pulmonar Disease + Sleep Apnea Syndrome ) with Dynamic Hyperinflation. EDIN-IDIN. (EDIN-IDIN)

November 27, 2024 updated by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Herminia Buchelli Ramirez Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD
  • Phone Number: Exts 369422/36 TFL: 968369500.
  • Email: fjose.ruiz1@um.es

Study Contact Backup

  • Name: Francisco José Ruiz López Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD
  • Phone Number: Exts 369422/36 968369500
  • Email: fjose.ruiz1@um.es

Study Locations

  • Spain
      • Murcia, Spain, 30120
        • Servicio de Neumología. Hospital Universitario Virgen de la Arrixaca.
        • Contact:
          • Francisco José Ruiz López Ruiz Lopez, MD
          • Phone Number: Exts 369422/36 968369500
          • Email: fjose.ruiz1@um.es
        • Contact:
          • Francisco José Ruiz López Ruiz Lopez, MD
        • Contact:
          • Herminia Buchelli Ramirez Buchelli Ramirez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Having had an exacerbation 4 weeks prior.
  • Severe psychiatric illness.
  • Cognitive impairment.
  • Not speaking Spanish.
  • Illiteracy.
  • Active smoker (or < 6 months since quitting smoking).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FIXED PRESSURE
Home nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days
Procedure: Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode
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.
Active Comparator: B
Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode for 28 days.
Procedure: Fixed pressure obtained in the polysomnography for 28 days
home nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak VO2
Time Frame: 0,29 and 57 days.
Peak VO2 as the primary variable obtained from cycle ergometry.
0,29 and 57 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VO2 max
Time Frame: 0,29 and 57 days.
VO2 max as a secondary variable obtained from cycle ergometry
0,29 and 57 days.
Anaerobic threshold
Time Frame: 0,29 and 57 days.
Anaerobic threshold as a secondary variable obtained from cycle ergometry.
0,29 and 57 days.
VE/VCO2
Time Frame: 0,29 and 57 days.
The slope of VE/VCO2 obtained from cycle ergometry and resting PEtCO2.
0,29 and 57 days.
BODE INDEX. (body mass index,)
Time Frame: 0,29 and 57 days.
Polysomnography
0,29 and 57 days.
BODE INDEX. ( air-flow obstruction)
Time Frame: 0,29 and 57 days.
Time in hypoventilation period both during wakefulness and sleep, and as a function of total sleep time.
0,29 and 57 days.
BODE INDEX. (dyspnea, )
Time Frame: 0,29 and 57 days.
number of residual respiratory events, time in hypoventilation period both during wakefulness and sleep, and as a function of total sleep time.
0,29 and 57 days.
BODE INDEX. (exercise capacity)
Time Frame: 0,29 and 57 days.
0,29 and 57 days.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Epworth scale
Time Frame: 0,29 and 57 days.
Based on a scale of (0 to 24 points)
0,29 and 57 days.
Analytical parameters
Time Frame: 0,29 and 57 days.
CAT u/ml
0,29 and 57 days.
Analytical parameters
Time Frame: 0,29 and 57 days.
ProBNP pg/mL
0,29 and 57 days.
Analytical parameters
Time Frame: 0,29 and 57 days.
C-reactive protein mg/dL
0,29 and 57 days.
Analytical parameters
Time Frame: 0,29 and 57 days.
pH
0,29 and 57 days.
Analytical parameters
Time Frame: 0,29 and 57 days.
pO2 mmHg, pCO2 mmHg
0,29 and 57 days.
Analytical parameters
Time Frame: 0,29 and 57 days.
sHCO3 mmol/L
0,29 and 57 days.
Analytical parameters
Time Frame: 0,29 and 57 days.
SatO2 %
0,29 and 57 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EDIN-IDIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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