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

• Sponsor: Centro Universitario La Salle (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06150677
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Hypoxia; Hypercapnia; Apnea	Other: Voluntary apnoea	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Static Apnea at High Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	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).
No Intervention: 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

Outcome Measures

Primary Outcome Measures

1. Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7 [before and after intervention (up 30 minutes)]

   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).

Secondary Outcome Measures

1. Perceived Stress Scale (PSS) [before intervention (up 5 minutes)]

   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.

2. Pittsburg Sleep Quality Index (PSQI) [before intervention (up 5 minutes)]

   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.

3. Global Physical Activity Questionnaire (GPAQ) [before intervention (up 5 minutes)]

   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

4. Oxygen saturation [during intervention (up 6 minutes)]

   Oxygen saturation will be measured during the procedure by finger pulse oximetry.

5. Heart rate [during intervention (up 6 minutes)]

   Heart rate will be measured during the procedure by finger pulse oximetry.

6. Blood pressure [before, during and after intervention (up 10 minutes)]

   Systolic and diastolic blood pressure will be measured before, during and immediately after the procedure using a digital wrist sphygmomanometer.

7. Rate of perceived exertion (RPE) [immediately after intervention (up 10 seconds)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CSEU LaSalle	Madrid		Spain

Sponsors and Collaborators

• Centro Universitario La Salle

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fran de Asís Fernández, Director, Centro Universitario La Salle
• ClinicalTrials.gov Identifier: NCT06150677
• Other Study ID Numbers: CSEULS-PI-015/2023
• First Posted: Nov 29, 2023
• Last Update Posted: Dec 1, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Apnea; Hypoxia; Hypercapnia

Study Results

No Results Posted as of Dec 1, 2023