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

Phase 3
Recruiting
Conditions
Pain
Hypoxia
Hypercapnia
Apnea
Interventions
Other: Voluntary apnoea
Registration Number
NCT06150677
Lead Sponsor
Centro Universitario La Salle
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Static apnea at High Lung VolumeVoluntary apnoeaParticipants 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).
Primary Outcome Measures
NameTimeMethod
Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7before 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
NameTimeMethod
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.

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

Blood pressurebefore, 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.

Oxygen saturationduring intervention (up 6 minutes)

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

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.

Heart rateduring intervention (up 6 minutes)

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

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.

Trial Locations

Locations (1)

CSEU LaSalle

🇪🇸

Madrid, Spain

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