HALOA: Cardiac Coherence With CPAP for Obstructive Sleep Apnea
NCT07929064, Not applicable, Not yet recruiting, Clinique du Millenaire
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | HALOA: Cardiac Coherence With CPAP for Obstructive Sleep Apnea | ClinicalTrials.gov |
| NCT number | NCT07929064 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 180 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Clinique du Millenaire | ClinicalTrials.gov |
| Conditions | Obstructive Sleep Apnea (OSA), OSA | ClinicalTrials.gov |
| Interventions | HALOA Continuous Positive Airway Pressure (CPAP), Cardiac Coherence Breathing Module | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Global Pittsburgh Sleep Quality Index (PSQI) Score | Baseline to week 8 | Absolute change in the global PSQI score from baseline (V1) to week 8 (V2), comparing the randomized groups. PSQI scores range from 0 to 21; higher scores indicate poorer sleep quality. | ClinicalTrials.gov |
| Secondary | Change in PSQI Score After Delayed Initiation of Cardiac Coherence | Week 8 to week 16 | Absolute change in global PSQI score from week 8 (V2) to week 16 (V3) in the delayed-intervention group, after the cardiac coherence module is activated. | ClinicalTrials.gov |
| Secondary | Change in Daytime Sleepiness | Baseline, week 8, and week 16 | Changes in Epworth Sleepiness Scale (ESS) | ClinicalTrials.gov |
| Secondary | Change in insomnia symptoms | Baseline, week 8, and week 16 | Changes in Insomnia Severity Index (ISI) | ClinicalTrials.gov |
| Secondary | Change in depression symptoms | Baseline, week 8, and week 16 | Changes in Hospital Anxiety and Depression Scale anxiety and depression subscale scores (HADS-A and HADS-D). | ClinicalTrials.gov |
| Secondary | Patient Satisfaction | Baseline, week 8, and week 16, as applicable | Patient satisfaction measured using the Client Satisfaction Questionnaire (CSQ-8) and the study-specific S-HALOA-CC questionnaire. S-HALOA-CC results will be considered exploratory. | ClinicalTrials.gov |
| Secondary | Usability of the Cardiac Coherence Module | Week 8 for the immediate-intervention group and week 16 for the delayed-intervention group | Usability measured using the System Usability Scale (SUS) after exposure to the cardiac coherence module. | ClinicalTrials.gov |
| Secondary | CPAP Adherence | At weeks 8 and 16; device use assessed over the 7-day and 30-day periods before each visit | Mean nightly CPAP use and the proportion of participants meeting the protocol-defined adherence threshold of at least 4 hours per night on at least 70% of nights. | ClinicalTrials.gov |
| Secondary | Heart-Rate Variability | Baseline and week 16, when recordings are available | Changes in time-domain and frequency-domain heart-rate variability indices derived from polysomnography recordings, when follow-up recordings are available. | ClinicalTrials.gov |
| Secondary | Clinically Meaningful Improvement in Sleep Quality | Baseline to week 8, week 8 to week 16, and baseline to week 16 | Proportion of participants with a decrease of at least 3 points in global PSQI score over the specified assessment interval. | 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 0
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 |
|---|
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)