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HALOA: Cardiac Coherence With CPAP for Obstructive Sleep Apnea (HALOA)

5 novembre 2026 aggiornato da: Bughin Francois, Clinique du Millenaire

Effect of Adding Cardiac Coherence to Continuous Positive Airway Pressure in Patients With Obstructive Sleep Apnea: A Multicenter Randomized Delayed-Start Controlled Study

This multicenter study will evaluate whether adding cardiac coherence breathing sessions to continuous positive airway pressure (CPAP) improves sleep quality in adults with newly diagnosed obstructive sleep apnea who are starting CPAP. Approximately 180 participants will be randomly assigned to one of two groups. Both groups will start treatment with the HALOA CPAP system. In one group, the cardiac coherence module will be activated at the start of treatment. In the other group, participants will use CPAP alone for 8 weeks before the module is activated.

Sleep quality will be assessed at study entry, at 8 weeks, and at 16 weeks using the Pittsburgh Sleep Quality Index. The primary comparison will assess the change in sleep quality from study entry to week 8 between the two groups. Secondary assessments will include daytime sleepiness, insomnia symptoms, anxiety and depression symptoms, treatment satisfaction, usability of the cardiac coherence module, CPAP use, and heart-rate variability when polysomnography recordings are available.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Obstructive sleep apnea is commonly treated with continuous positive airway pressure (CPAP). However, some patients have difficulty adhering to CPAP or experience persistent sleep-related symptoms. Cardiac coherence is a guided breathing practice intended to support relaxation and emotional regulation. The HALOA system combines CPAP treatment with a cardiac coherence module. This study will assess whether access to this module from the start of CPAP treatment improves subjective sleep quality compared with starting the module after an initial period of CPAP alone.

This is a prospective, multicenter, randomized, open-label, delayed-start controlled study. Approximately 180 adults with newly diagnosed obstructive sleep apnea and an indication for CPAP will be enrolled at 11 planned centers. Participants will be randomly assigned in equal numbers to one of two groups.

All participants will begin CPAP treatment using the HALOA system and will receive usual CPAP care. Participants in the immediate-intervention group will have the cardiac coherence module activated at study entry and will receive guidance on its use. Participants in the delayed-intervention group will use CPAP without cardiac coherence for the first 8 weeks. After the week 8 assessment, the module will be activated and participants will receive guidance on its use.

Study assessments will take place at baseline, week 8, and week 16. The primary outcome is the change in the global Pittsburgh Sleep Quality Index (PSQI) score from baseline to week 8, comparing the two randomized groups. The week 8 assessment provides the controlled comparison before participants in the delayed-intervention group begin cardiac coherence. Changes in PSQI from week 8 to week 16 in the delayed-intervention group will also be assessed to explore the effect after the module is introduced.

Secondary assessments will include daytime sleepiness using the Epworth Sleepiness Scale, insomnia symptoms using the Insomnia Severity Index, and anxiety and depression symptoms using the Hospital Anxiety and Depression Scale. Patient satisfaction will be assessed using the CSQ-8 and a study-specific questionnaire. Usability of the cardiac coherence module will be assessed using the System Usability Scale. CPAP adherence will be evaluated using device data, including hours of use and the proportion of participants meeting the protocol-defined adherence threshold. Heart-rate variability indices will be evaluated from polysomnography recordings when available.

Participants will be adults with obstructive sleep apnea diagnosed by polysomnography within the 3 months before inclusion and for whom CPAP treatment is indicated. The protocol lists recent CPAP or mandibular advancement device treatment, refusal of or contraindication to CPAP, inability to use the cardiac coherence device, and specified medical, psychiatric, or other circumstances among the non-inclusion criteria.

Tipo di studio

Interventistico

Iscrizione (Stimato)

180

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: François FB Bughin, Md, PhD
  • Numero di telefono: 0033761783081
  • Email: fbughin@hotmail.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Age 18 years or older.
  • Obstructive sleep apnea diagnosed according to ICSD-3 criteria by polysomnography performed within 3 months before study inclusion.
  • Indication for CPAP treatment according to current recommendations: apnea-hypopnea index (AHI) ≥30 events/hour, or AHI ≥15 events/hour with severe cardiovascular or respiratory comorbidity.
  • Written informed consent.

Exclusion Criteria:

  • CPAP or mandibular advancement device treatment within the 3 months before inclusion.
  • Refusal of CPAP treatment.
  • Contraindication to CPAP treatment.
  • Unstable psychiatric disorder or substance-use disorder.
  • Technical inability to use the cardiac coherence device.
  • Not affiliated with, or not a beneficiary of, a social security system.
  • Deprivation of liberty by judicial or administrative decision.
  • Legal protective measure, including guardianship or curatorship.
  • Pregnancy, childbirth, or breastfeeding.
  • Language barrier preventing participation.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Immediate cardiac coherence with CPAP

Participants will start HALOA CPAP at study inclusion. The cardiac coherence breathing module will be activated from the start of treatment, with guidance on its use. Participants will be assessed at baseline, week 8, and week 16.
Dispositivo: HALOA Continuous Positive Airway Pressure (CPAP)

CPAP treatment using the HALOA system, initiated at study inclusion in both groups and provided as part of usual care.

Comportamentale: Cardiac Coherence Breathing Module

Guided cardiac coherence breathing sessions using the module integrated with the HALOA system. The module is activated at study inclusion in the experimental group and after the week 8 assessment in the active comparator group.
Comparatore attivo: Delayed cardiac coherence with CPAP

Participants will start HALOA CPAP at study inclusion and use it without the cardiac coherence module for 8 weeks. After the week 8 assessment, the module will be activated and guidance on its use provided. Participants will be assessed at baseline, week 8, and week 16.
Dispositivo: HALOA Continuous Positive Airway Pressure (CPAP)

CPAP treatment using the HALOA system, initiated at study inclusion in both groups and provided as part of usual care.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Global Pittsburgh Sleep Quality Index (PSQI) Score
Lasso di tempo: 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.
Baseline to week 8

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in PSQI Score After Delayed Initiation of Cardiac Coherence
Lasso di tempo: 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.
Week 8 to week 16
Change in Daytime Sleepiness
Lasso di tempo: Baseline, week 8, and week 16

Changes in Epworth Sleepiness Scale (ESS)
Baseline, week 8, and week 16
Change in insomnia symptoms
Lasso di tempo: Baseline, week 8, and week 16

Changes in Insomnia Severity Index (ISI)
Baseline, week 8, and week 16
Change in depression symptoms
Lasso di tempo: Baseline, week 8, and week 16

Changes in Hospital Anxiety and Depression Scale anxiety and depression subscale scores (HADS-A and HADS-D).
Baseline, week 8, and week 16
Patient Satisfaction
Lasso di tempo: 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.
Baseline, week 8, and week 16, as applicable
Usability of the Cardiac Coherence Module
Lasso di tempo: 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.
Week 8 for the immediate-intervention group and week 16 for the delayed-intervention group
CPAP Adherence
Lasso di tempo: 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.
At weeks 8 and 16; device use assessed over the 7-day and 30-day periods before each visit
Heart-Rate Variability
Lasso di tempo: 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.
Baseline and week 16, when recordings are available
Clinically Meaningful Improvement in Sleep Quality
Lasso di tempo: 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.
Baseline to week 8, week 8 to week 16, and baseline to week 16

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Clinique du Millenaire

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

5 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 novembre 2026

Primo Inserito (Effettivo)

10 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 26.01725.000477

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

The sponsor has not yet determined whether individual participant data and the corresponding data dictionary will be made available to other researchers. The plan will be updated once a decision has been made.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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