Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06713486

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio de Neumología. Hospital Universitario Virgen de la Arrixaca.

Murcia, 30120, Spain

Location contact

Francisco José Ruiz López Ruiz Lopez, MD

CONTACT

[email protected]

968369500 ext. Exts 369422/36

Francisco José Ruiz López Ruiz Lopez, MD

CONTACT

Herminia Buchelli Ramirez Buchelli Ramirez, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Fixed pressure obtained in the polysomnography for 28 days

Procedure

home nocturnal therapy either at the fixed pressure obtained in the polysomnography for 28 days

Dynamic pressure in Dreamstation AVAPS-AAM PhilipsRespironic® mode

Procedure

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.

Primary outcomes

  1. Peak VO2

    Time frame: 0,29 and 57 days.

    Peak VO2 as the primary variable obtained from cycle ergometry.

Secondary outcomes

  1. VO2 max

    Time frame: 0,29 and 57 days.

    VO2 max as a secondary variable obtained from cycle ergometry

  2. Anaerobic threshold

    Time frame: 0,29 and 57 days.

    Anaerobic threshold as a secondary variable obtained from cycle ergometry.

  3. VE/VCO2

    Time frame: 0,29 and 57 days.

    The slope of VE/VCO2 obtained from cycle ergometry and resting PEtCO2.

  4. BODE INDEX. (body mass index,)

    Time frame: 0,29 and 57 days.

    Polysomnography

  5. 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.

  6. 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.

  7. BODE INDEX. (exercise capacity)

    Time frame: 0,29 and 57 days.

Other outcomes

  1. Epworth scale

    Time frame: 0,29 and 57 days.

    Based on a scale of (0 to 24 points)

  2. Analytical parameters

    Time frame: 0,29 and 57 days.

    CAT u/ml

  3. Analytical parameters

    Time frame: 0,29 and 57 days.

    ProBNP pg/mL

  4. Analytical parameters

    Time frame: 0,29 and 57 days.

    C-reactive protein mg/dL

  5. Analytical parameters

    Time frame: 0,29 and 57 days.

    pH

  6. Analytical parameters

    Time frame: 0,29 and 57 days.

    pO2 mmHg, pCO2 mmHg

  7. Analytical parameters

    Time frame: 0,29 and 57 days.

    sHCO3 mmol/L

  8. Analytical parameters

    Time frame: 0,29 and 57 days.

    SatO2 %

Study contacts

Contact information is provided by the study sponsor or research team.

Francisco José Ruiz López Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD

CONTACT

[email protected]

968369500 ext. Exts 369422/36

Herminia Buchelli Ramirez Servicio de Neumología. Hospital Universitario Virgen de la Ar, MD

CONTACT

[email protected]

TFL: 968369500. ext. Exts 369422/36

Sponsors and collaborators

Lead sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Other

Registry information

Acronym: EDIN-IDIN

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.