An interventional study of HALOA Continuous Positive Airway Pressure (CPAP) and Cardiac Coherence Breathing Module in Obstructive Sleep Apnea (OSA) and OSA, sponsored by Clinique du Millenaire. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Clinique du Millenaire · Not applicable, Interventional, and Treatment
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.
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 180 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Clinique du Millenaire is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: HALOA Continuous Positive Airway Pressure (CPAP) · Behavioral: Cardiac Coherence Breathing Module
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.
Device: 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.
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.
Change in Global Pittsburgh Sleep Quality Index (PSQI) Score
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.
Time frame: Baseline to week 8
Change in PSQI Score After Delayed Initiation of Cardiac Coherence
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.
Time frame: Week 8 to week 16
Change in Daytime Sleepiness
Changes in Epworth Sleepiness Scale (ESS)
Time frame: Baseline, week 8, and week 16
Change in insomnia symptoms
Changes in Insomnia Severity Index (ISI)
Time frame: Baseline, week 8, and week 16
Change in depression symptoms
Changes in Hospital Anxiety and Depression Scale anxiety and depression subscale scores (HADS-A and HADS-D).
Time frame: Baseline, week 8, and week 16
Patient Satisfaction
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.
Time frame: Baseline, week 8, and week 16, as applicable
Usability of the Cardiac Coherence Module
Usability measured using the System Usability Scale (SUS) after exposure to the cardiac coherence module.
Time frame: Week 8 for the immediate-intervention group and week 16 for the delayed-intervention group
CPAP Adherence
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.
Time frame: At weeks 8 and 16; device use assessed over the 7-day and 30-day periods before each visit
Heart-Rate Variability
Changes in time-domain and frequency-domain heart-rate variability indices derived from polysomnography recordings, when follow-up recordings are available.
Time frame: Baseline and week 16, when recordings are available
Clinically Meaningful Improvement in Sleep Quality
Proportion of participants with a decrease of at least 3 points in global PSQI score over the specified assessment interval.
Time frame: Baseline to week 8, week 8 to week 16, and baseline to week 16
No study locations are listed for this record.
Plan to share: Undecided — 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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