A Phase 3 interventional study of Voluntary apnoea in Pain, Hypoxia and Hypercapnia, sponsored by Centro Universitario La Salle. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Centro Universitario La Salle · Phase 3, Interventional, and Treatment
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Centro Universitario La Salle is the lead sponsor of 25 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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).
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).
Time frame: before and after intervention (up 30 minutes)
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.
Time frame: before intervention (up 5 minutes)
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.
Time frame: before intervention (up 5 minutes)
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
Time frame: before intervention (up 5 minutes)
Oxygen saturation
Oxygen saturation will be measured during the procedure by finger pulse oximetry.
Time frame: during intervention (up 6 minutes)
Heart rate
Heart rate will be measured during the procedure by finger pulse oximetry.
Time frame: during intervention (up 6 minutes)
Blood pressure
Systolic and diastolic blood pressure will be measured before, during and immediately after the procedure using a digital wrist sphygmomanometer.
Time frame: before, during and after intervention (up 10 minutes)
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.
Time frame: immediately after intervention (up 10 seconds)
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for May 2025, 17 months after the start.
Of 110 non-industry phase 3 interventional studies under Pain, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 17 months is below that.
Counting every sponsor, half of 215 studies reached it within 18 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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Centro Universitario La Salle