Understanding health impacts of sleep apnea
Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea
This study is testing how sleep apnea affects heart and brain health in adults who haven't started treatment yet, while also trying out CPAP to see how it helps.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04575740 on ClinicalTrials.gov |
What this trial studies
This study aims to better characterize the physiological consequences of obstructive sleep apnea (OSA) by using advanced metrics to assess hypoxemia, heart rate response, and sleep fragmentation. By focusing on these specific physiological factors, the researchers hope to improve the understanding of how OSA affects neurocognitive and cardiovascular health. Participants will be adults diagnosed with moderate to severe OSA who have not yet received treatment. The study will utilize continuous positive airway pressure (CPAP) as an intervention to evaluate its effects on these newly characterized metrics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-80 with a diagnosis of moderate to severe obstructive sleep apnea and an apnea-hypopnea index greater than 15 events/hr.
Not a fit: Patients currently receiving treatment for obstructive sleep apnea or those with uncontrolled medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with sleep apnea, potentially reducing adverse health outcomes.
How similar studies have performed: While previous studies have explored CPAP's effects, this approach of detailed physiological characterization is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Adults aged 21-80 years. * Participants with a previous diagnosis of moderate to severe obstructive sleep will be eligible to enroll and attend the baseline study. Patients with a total apnea-hypopnea index greater than 15 events/hr on the baseline study will be eligible for further participation. Exclusion criteria: * Current treatment for obstructive sleep apnea (including CPAP, oral appliances, supplemental oxygen). Patients must be untreated prior to the baseline visit. * Use of medications that might depress respiration (including opioids, barbiturates, benzodiazepines, and Z drugs, including zolpidem, zopiclone, eszopiclone, and zaleplon). * Active use of non-prescription opioids (e.g., cocaine, methamphetamine) * Uncontrolled medical problem or major organ system disease, which, in the opinion of the investigators (PI and Co-Is), would interfere with the evaluation of the subject (e.g., uncontrolled hypertension, unstable coronary heart disease, etc.). * History of congestive heart failure, renal insufficiency, systemic neurological condition that could affect respiration. * Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea: * central sleep apnea (\>50% of respiratory events scored as central), * chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions. * Other sleep disorders: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias. * Patients unable or unwilling to use CPAP. * Insomnia or insufficient sleep (self-reported inability to sleep \>6 hrs night). * Pregnancy (women)
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Ali Azarbarzin, PhD — Brigham and Women's Hospital
- Study coordinator: Nkiru G Ujomu
- Email: nujomu@bwh.harvard.edu
- Phone: 617-732-8976
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.