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

NCT06150677 | Unknown Phase 3

• 1 other identifier: CSEULS-PI-015/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7

  PPT is tested on the dorsal base of the distal phalanx of the thumb on the dominant side and on the muscle belly of the tibialis anterior on the dominant side. The region to be pressed is marked with a pen. The patient is instructed to report with the first appearance of the sensation of "discomfort". An ascending ramp of 0.5 kg/cm/s is applied, at the rhythm of a metronome. The measurement is started on the thumb, and alternated with tibia and C7 until 3 measurements of each region are obtained, enough time to give 30 seconds of rest between measurements in the same region. This protocol has demonstrated high inter-observer reliability measuring healthy subjects (ICC = 0.91).

  before and after intervention (up 30 minutes)

Secondary Outcomes (7)

• Perceived Stress Scale (PSS)

  before intervention (up 5 minutes)

• Pittsburg Sleep Quality Index (PSQI)

  before intervention (up 5 minutes)

• Global Physical Activity Questionnaire (GPAQ)

  before intervention (up 5 minutes)

• Oxygen saturation

  during intervention (up 6 minutes)

• Heart rate

  during intervention (up 6 minutes)

Study Arms (2)

Static apnea at High Lung Volume

EXPERIMENTAL

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).

Other: Voluntary apnoea

Static at normal breathing

NO INTERVENTION

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

Interventions

Voluntary apnoea 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 apnea at High Lung Volume

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Asymptomatic subjects aged between 18 and 64 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitario La Salle: lead

Study Sites (1)

CSEU LaSalle

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Pain; Hypoxia; Hypercapnia; Apnea

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Fran DeAsís-Fernández

CONTACT

(0034)667000218; frandeasis@lasallecampus.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 29, 2023
• Study Start: December 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)