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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150677
• Other study ID #: CSEULS-PI-015/2023
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: January 2024
• Source: Centro Universitario La Salle
• Contact: Fran DeAsís-Fernández
• Phone: (0034)667000218
• Email: frandeasis[@]lasallecampus.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Hypercapnia
• Hypoxia
• Pain

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Spain	CSEU LaSalle	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitario La Salle

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Perceived Stress Scale (PSS)	14-item questionnaire about their thoughts and feelings in the last month. The scale has a range of scores from 0 to 56. The lower the score, the more favorable for the patient's health.	before intervention (up 5 minutes)
Secondary	Pittsburg Sleep Quality Index (PSQI)	9-item questionnaire on sleep quality in the past month. The scale has a range of scores from 0 to 21. The lower the score, the more favorable for the patient's health.	before intervention (up 5 minutes)
Secondary	Global Physical Activity Questionnaire (GPAQ)	6-item questionnaire on the level of physical activity at work, for commuting and in leisure time. A higher score means higher weekly physical activity	before intervention (up 5 minutes)
Secondary	Oxygen saturation	Oxygen saturation will be measured during the procedure by finger pulse oximetry.	during intervention (up 6 minutes)
Secondary	Heart rate	Heart rate will be measured during the procedure by finger pulse oximetry.	during intervention (up 6 minutes)
Secondary	Blood pressure	Systolic and diastolic blood pressure will be measured before, during and immediately after the procedure using a digital wrist sphygmomanometer.	before, during and after intervention (up 10 minutes)
Secondary	Rate of perceived exertion (RPE)	RPE Borg CR-10 is used to measure how hard your body works during physical activity. It runs from 0 - 10, using numbers to rate how much effort an activity takes.	immediately after intervention (up 10 seconds)