PainPhase 3NCT06158295
Effects of Walking Apnea at Low Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function
A Phase 3 study testing Voluntary apnoea in people with Pain and Hypoxia, run by Centro Universitario La Salle at 1 site in Spain.
Trial summary
The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at low lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Hypoxia, Hypercapnia
- What is being tested?
- Voluntary apnoea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2023to 1 May 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic subjects aged between 18 and 64 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
CSEU LaSalle
Madrid
Fran DeAsís-Fernández, PhD, (0034)667000218, frandeasis@lasallecampus.es
About this study
The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at low 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
- Being tested
- Voluntary apnoea
- Medical subject headings
- Pain, Hypoxia, Hypercapnia, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voluntary apnoeaOther
Walking apneas at low lung volume
| Study group | Role | What they receive |
|---|---|---|
| Walking apnea at Low Lung Volume | Experimental | Participants walk at 5,5 km/h on treadmill for 6 minutes. Participants in the experimental group will perform intermittent apneas at low lung volume with a density of 15 seconds, followed by a normal breath of 10 seconds (15 cycles of 15s apnea - 10s normal breathing, until completing the 6 minutes). Receives: Other: Voluntary apnoea |
| Walking at normal breathing | No intervention | Participants walk at 5,5 km/h on treadmill for 6 minutes. Participants in the control group will remain breathing normally for these 6 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: before and after intervention (up 30 minutes)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: before intervention (up 5 minutes)
Heart rate
Heart rate will be measured during the procedure by finger pulse oximetry.
Measured: during intervention (up 6 minutes)
Oxygen saturation
Oxygen saturation will be measured during the procedure by finger pulse oximetry.
Measured: 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.
Measured: 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.
Measured: immediately after intervention (up 10 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Dec 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fran de Asís Fernández, Centro Universitario La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158295
- Sponsor's protocol ID
- CSEULS-PI-018/2023
- Status last verified
- Jan 2024
- First submitted
- 18 Nov 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Walking Apnea at Low Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function
- ClinicalTrials.gov ID
- NCT06158295
- Acronym / sponsor ID
- CSEULS-PI-018/2023
- Conditions
- Pain, Hypoxia, Hypercapnia, Apnea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at low lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking apnea at Low Lung Volume | Experimental | Other: Voluntary apnoeaParticipants walk at 5,5 km/h on treadmill for 6 minutes. Participants in the experimental group will perform intermittent apneas at low lung volume with a density of 15 seconds, followed by a normal breath of 10 seconds (15 cycles of 15s apnea - 10s normal breathing, until completing the 6 minutes). |
| Walking at normal breathing | No intervention | –Participants walk at 5,5 km/h on treadmill for 6 minutes. Participants in the control group will remain breathing normally for these 6 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Asymptomatic subjects aged between 18 and 64 years.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voluntary apnoeaWalking apneas at low lung volume | Other | Walking apnea at Low Lung Volume |
Primary outcome
Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7
Time frame: 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).
7 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: before intervention (up 5 minutes)
Pittsburg Sleep Quality Index (PSQI)
Time frame: before intervention (up 5 minutes)
Global Physical Activity Questionnaire (GPAQ)
Time frame: before intervention (up 5 minutes)
Heart rate
Time frame: during intervention (up 6 minutes)
Oxygen saturation
Time frame: during intervention (up 6 minutes)
Blood pressure
Time frame: before, during and after intervention (up 10 minutes)
Rate of perceived exertion (RPE)
Time frame: immediately after intervention (up 10 seconds)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Voluntary apnoea in people with Pain and Hypoxia, run by Centro Universitario La Salle at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7 (time frame: before and after intervention (up 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.