Investigating the Combined Effects of Intermittent Hypoxia and Exercise on Cognitive and Cerebral Function in Middle-Aged Adults
NCT06874387, Not applicable, Not yet recruiting, Ayoub Boulares
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Investigating the Combined Effects of Intermittent Hypoxia and Exercise on Cognitive and Cerebral Function in Middle-Aged Adults | ClinicalTrials.gov |
| NCT number | NCT06874387 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 176 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Ayoub Boulares | ClinicalTrials.gov |
| Conditions | Cognitive Ability, General, Brain Health, Cerebral Oxygenation | ClinicalTrials.gov |
| Interventions | Hypoxia, intermittent, physical exercise, Sham (No Treatment) hypoxia | ClinicalTrials.gov |
| First posted | 2025-03-13 | ClinicalTrials.gov |
| Last updated | 2025-03-13 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cognitive Function: Montreal Cognitive Assessment (MoCA) | Baseline (Week 0),Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | 1-Montreal Cognitive Assessment (MoCA) * Score Range: 0 to 30 * Interpretation: Higher scores indicate better cognitive function. | ClinicalTrials.gov |
| Primary | Cerebral Oxygenation - Tissue Saturation Index (TSI) | Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | * Method: Near-Infrared Spectroscopy (NIRS) * Measure: Tissue Saturation Index (TSI), expressed as a percentage (%) * Interpretation: Higher TSI values indicate better cerebral oxygenation, reflecting efficient oxygen delivery and utilization in brain tissue. | ClinicalTrials.gov |
| Primary | Biomarker Analysis- Brain-Derived Neurotrophic Factor (BDNF) Levels | Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | * Method: Enzyme-Linked Immunosorbent Assay (ELISA) * Unit of Measure: pg/mL * Interpretation: Higher BDNF levels indicate greater neuroplasticity, neuronal survival, and cognitive function support. | ClinicalTrials.gov |
| Primary | Cerebral blood flow | Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | Method: Transcranial Doppler (TCD) Measures: Mean, systolic, and diastolic blood flow velocities in cerebral arteries. Interpretation: Higher flow velocities indicate increased cerebral perfusion, while reduced velocities may reflect impaired blood flow regulation or vascular resistance. | ClinicalTrials.gov |
| Primary | Cognitive Function: Stroop Test | Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | The Stroop Test is a widely used cognitive assessment tool designed to measure executive function, specifically selective attention, cognitive flexibility, and inhibitory control. It evaluates the ability to suppress automatic responses and manage conflicting information. -Score Range: Reaction Time (measured in milliseconds, ms): Represents the time taken to respond in each condition. Accuracy Percentage (%): Indicates the proportion of correct responses relative to total trials. -Interpretation: Lower reaction times indicate faster cognitive processing and improved efficiency in managing conflicting information. Higher accuracy percentages reflect better cognitive control, attentional capacity, and inhibitory function. Performance in the incongruent condition is of particular interest, as it requires greater cognitive effort and executive control. | ClinicalTrials.gov |
| Primary | Cognitive Function: N-Back | Baseline (Week 0),Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | The N-Back Test is a cognitive task designed to assess working memory, attention, and cognitive flexibility. It requires participants to continuously monitor a sequence of stimuli (e.g., letters, numbers, or shapes) and determine whether the current stimulus matches one presented N steps earlier in the sequence. The task increases in difficulty as N increases, demanding greater mental effort to update and maintain information in working memory. -Score Range: Accuracy Percentage (%): Proportion of correct responses over total trials. Reaction Time (ms): Time taken to respond to correct matches. -Interpretation: Higher accuracy reflects better working memory capacity and attentional control. Faster reaction times indicate efficient cognitive processing. Performance decline in higher N levels suggests increased cognitive load and reduced working memory capacity. Deficits in accuracy or reaction time may indicate difficulties in executive function and attentional flexibility. | ClinicalTrials.gov |
| Primary | Cognitive Function:Operation Span Test Task | Baseline (Week 0),Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | The Operation Span (O-Span) Test is a cognitive task designed to assess working memory capacity and attentional control. It requires participants to simultaneously process and store information, challenging their ability to maintain and manipulate information while handling a secondary task. The test includes: Two training trials for familiarization. Six experimental trials, with letter sequences ranging from four to six letters. -Score Range: Absolute Span Score: 0 to 12 (number of correctly recalled letter sequences). Interpretation: Higher scores indicate greater working memory capacity and better attentional control. Lower scores may suggest difficulties in managing cognitive load and maintaining task-relevant information under distraction. Performance reflects the ability to simultaneously process and store information, which is critical for complex cognitive tasks such as reasoning, problem-solving, and multitasking. | ClinicalTrials.gov |
| Primary | Cognitive Function: The Trail Making Test | Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | The Trail Making Test (TMT) is a widely used neuropsychological assessment designed to evaluate processing speed, cognitive flexibility, attention, and executive functioning. It consists of two parts: * TMT-A: Measures visual scanning, processing speed, and motor function. Participants connect numbers in ascending order (e.g., 1 → 2 → 3) as quickly as possible. * TMT-B: Assesses cognitive flexibility and task-switching ability. Participants alternate between numbers and letters in sequential order (e.g., 1 → A → 2 → B → 3 → C). * Score Range: Outcome Measure: Time (in seconds) taken to complete each part. Higher scores (longer times) indicate slower processing speed and reduced cognitive flexibility. -Interpretation: Lower scores (faster completion time) indicate better processing speed, visual attention, and cognitive flexibility. Higher scores (longer completion time) may reflect impairments in executive function, attention, or visuomotor speed. | ClinicalTrials.gov |
| Primary | Cerebral Oxygenation - Oxyhemoglobin (O₂Hb) | Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | * Method: Near-Infrared Spectroscopy (NIRS) * Measure: Oxyhemoglobin (O₂Hb), expressed in micromolar concentration (µM) * Interpretation: Higher O₂Hb levels indicate greater oxygen availability and delivery to brain tissues. | ClinicalTrials.gov |
| Primary | Cerebral Oxygenation - Deoxyhemoglobin (HHb) | Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | * Method: Near-Infrared Spectroscopy (NIRS) * Measure: Deoxyhemoglobin (HHb), expressed in micromolar concentration (µM) * Interpretation: Elevated HHb levels may suggest reduced oxygen extraction or utilization, potentially indicating impaired cerebral oxygenation. | ClinicalTrials.gov |
| Primary | Cerebral Oxygenation - Total Hemoglobin (tHb) | Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | * Method: Near-Infrared Spectroscopy (NIRS) * Measure: Total Hemoglobin (tHb), expressed in micromolar concentration (µM) * Interpretation: Higher tHb values reflect greater blood volume in cerebral tissue, which may indicate increased cerebral perfusion. | ClinicalTrials.gov |
| Primary | Biomarker Analysis-Vascular Endothelial Growth Factor (VEGF) Levels | Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | * Method: Enzyme-Linked Immunosorbent Assay (ELISA) * Unit of Measure: pg/mL * Interpretation: Increased VEGF levels suggest enhanced angiogenesis, vascular function, and cerebral blood flow. | ClinicalTrials.gov |
| Primary | Biomarker Analysis -Irisin Levels | Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | * Method: Enzyme-Linked Immunosorbent Assay (ELISA) * Unit of Measure: ng/mL * Interpretation: Higher irisin levels indicate improved metabolic regulation, muscle-derived neuroprotection, and brain function. | ClinicalTrials.gov |
| Primary | Biomarker Analysis-Hypoxia-Inducible Factor-1 Alpha (HIF-1α) Pathway Activation | Baseline (Week 0), Week 1 (after 3 sessions), Week 6 (post-intervention, after session 18) | * Method: Quantitative Polymerase Chain Reaction (qPCR) / Western Blot * Unit of Measure: Relative expression level (fold change compared to baseline) * Interpretation: Increased HIF-1α activation suggests enhanced cellular adaptation to hypoxia, improved metabolic regulation, and potential neuroprotection. | ClinicalTrials.gov |
| Secondary | Autonomy and Daily Functioning (Activities of Daily Living Scale) | Baseline, and post-intervention (week 6, session 18) | * Full Name: Activities of Daily Living (ADL) Scale * Description: This scale assesses an individual's ability to perform essential daily activities independently. It evaluates functions such as dressing, bathing, eating, mobility, toileting, and grooming. * Score Range: 0 to 6 * Interpretation: A higher score indicates greater independence, while a lower score reflects higher dependency in daily functioning. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Primary outcome | ConductCognition |
| 2-Back Task | Primary outcome | ConductCognition |
| Operation Span | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Task Switching Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)