Effects of Static Apnea at High Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function

NCT ID: NCT06150677

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-05-01

Brief Summary

The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent static apneas training session at high lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.

Conditions

Pain; Hypoxia; Hypercapnia; Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Static apnea at High Lung Volume

Participants will remain at rest in the supine position for 6 minutes. Participants in the experimental group will perform intermittent apneas at high lung volume with a density of 30 seconds, followed by a normal breath of 10 seconds (9 cycles of 30s apnea - 10s normal breathing, until completing the 6 minutes).

Group Type: EXPERIMENTAL

Voluntary apnoea

Intervention Type: OTHER

Static apneas at high lung volume with a density of 30 seconds, followed by a normal breath of 10 seconds (9 cycles of 30s apnea - 10s normal breathing, until completing the 6 minutes).

Static at normal breathing

Participants will remain at rest in the supine position for 6 minutes. Participants in the control group will remain breathing normally for these 6 minutes

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Voluntary apnoea

Static apneas at high lung volume with a density of 30 seconds, followed by a normal breath of 10 seconds (9 cycles of 30s apnea - 10s normal breathing, until completing the 6 minutes).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria

• Cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies.
• History of epilepsy.
• Pregnant.
• Pharmacological treatment.
• Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Universitario La Salle

OTHER

Sponsor Role: lead

Responsible Party

Fran de Asís Fernández

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CSEU LaSalle

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Fran DeAsís-Fernández

Role: CONTACT

frandeasis@lasallecampus.es

(0034)667000218

Facility Contacts

Fran DeAsís-Fernández, PhD

Role: primary

Other Identifiers

CSEULS-PI-015/2023

Identifier Type: -

Identifier Source: org_study_id