Could Apnea Induce Hypoalgesia?

NCT ID: NCT05991141

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-05-15

Brief Summary

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A randomized controlled trial (RCT) in healthy subjects will be conducted with the following aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts, Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT.

Detailed Description

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A randomized controlled trial (RCT) in healthy subjects will be conducted with the following aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT

Conditions

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Pain Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Group

Experimental Group

Group Type EXPERIMENTAL

Apnea

Intervention Type OTHER

In both experimental and control groups participants walked on a treadmill at 5.5 km/h with 5º inclination for 6 minutes. The experimental group (EG) added throughout the 6 minutes intervention the following breathing pattern cyclically: 5 seconds breathing normally followed by 10 seconds of low volume apnoea, performing a total of 24 cycles of normal breathing continued by apnoea.

Control Group

Control Group

Group Type SHAM_COMPARATOR

Control Intervention

Intervention Type OTHER

In both experimental and control groups participants walked on a treadmill at 5.5 km/h with 5º inclination for 6 minutes. The Control group (CG) performed this protocol breathing normally.

Interventions

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Apnea

In both experimental and control groups participants walked on a treadmill at 5.5 km/h with 5º inclination for 6 minutes. The experimental group (EG) added throughout the 6 minutes intervention the following breathing pattern cyclically: 5 seconds breathing normally followed by 10 seconds of low volume apnoea, performing a total of 24 cycles of normal breathing continued by apnoea.

Intervention Type OTHER

Control Intervention

In both experimental and control groups participants walked on a treadmill at 5.5 km/h with 5º inclination for 6 minutes. The Control group (CG) performed this protocol breathing normally.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy participants
* 18-30 years
* Currently pain-free
* Basal SpO2 ≥95%

Exclusion Criteria

* Diabetes diagnosis
* Hypertension or hypotension diagnosis
* Pharmacological treatment
* Frequent pain during last month
* Drug consumption
* Self-harming behaviours
* Pregnant or potentially pregnant
* Cardiac or respiratory pathology
* Splenectomy or spleen disease
* Having performed moderate or high intensity physical activity 24 hours prior to the study
* Not having slept the previous night
* Alcohol intake 24 hours prior to study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centro Universitario La Salle

OTHER

Sponsor Role lead

Responsible Party

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José Fierro Marrero

Predoctoral researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Fierro Marrero

Role: PRINCIPAL_INVESTIGATOR

CSEULaSalle

Locations

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Centro Superior de Estudios La Salle

Madrid, , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CSEULS-PI-029/2022

Identifier Type: -

Identifier Source: org_study_id

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