NCT05991141

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

July 26, 2023

Last Update Submit

August 11, 2023

Conditions

PainApnea

Keywords

PainApnoeaApneaHypoalgesia

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold

    PPT refers to the minimal amount of pressure needed to cause the first sensation of pain. The mechanical pressure algometer (PAIN TEST™ FPX 25, Wagner Instruments, Greenwich, CT, USA) counted with a round rubber disc of 1 cm2, displaying values in Kg, hence, data was expressed in Kg/cm2. Two locations, in upper and lower limbs, were examined to examine systemic hypoalgesia effects. The dorsal distal-phalange base of the thumb and tibialis anterior muscle belly, both in the dominant limb, were tested. These regions were marked with a pen before assessments, to repeat the trials in the same place. Three trials were tested in each location, with 30 seconds rest between trials. Pressure speed was paced with a metronome applying a constant force of 0.5 Kg/cm2/s ± 0.1 Kg/cm2/s.

    Before and immediately after the interventions

Secondary Outcomes (3)

  • Conditioned pain modulation

    Before and immediately after the interventions

  • Heart Rate and Oxygen Saturation

    During the intervention and for 2 minutes additionally after the end of the intervention

  • Rated Perceived Exertion

    This outcome was assessed immediately after having finished the intervention protocols

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental Group

Other: Apnea

Control Group

SHAM COMPARATOR

Control Group

Other: Control Intervention

Interventions

ApneaOTHER

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.

Experimental Group
Control InterventionOTHER

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.

Control Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy participants
  • years
  • Currently pain-free
  • Basal SpO2 ≥95%

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Superior de Estudios La Salle

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

PainApnea

Interventions

N(6)-2-(4-aminophenyl)ethyladenosine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Study Officials

  • José Fierro Marrero

    CSEULaSalle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Predoctoral researcher

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 14, 2023

Study Start

February 1, 2023

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

ES(1)