COMPLETED

Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea

Conditions

Sleep Apnea Hypoxic burden Arousal intensity Post-event tachycardia Positive airway pressure Apnea hypopnea index

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Obstructive sleep apnea (OSA) is a highly prevalent disorder with adverse neurocognitive and cardio-metabolic outcomes. Continuous positive airway pressure (CPAP) is the gold standard therapeutic option to treat airway obstructions during sleep and thus, prevent its adverse cardiovascular and neurocognitive outcomes. Previous clinical trials, however, have largely failed to show a consistent impact of CPAP on these health outcomes. One of the main limitations of these trials may be the inadequate characterization of OSA and its acute physiological consequences. By characterizing OSA based on the "apnea-hypopnea index (AHI)", there is a potential risk of negative results. In this trial, the investigators intend to tackle this issue, by better characterization of OSA-related physiological consequences during sleep using physiologically driven metrics to capture the burden of OSA-related hypoxemia ("hypoxic burden"), autonomic response ("heart rate burden"), and sleep fragmentation ("arousal burden").

Official Title

Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea

Quick Facts

Study Start:2020-09-10

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04575740

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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)

Inclusion Criteria

Exclusion 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.

* 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)

Contacts and Locations

Principal Investigator

Ali Azarbarzin, PhD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Ali Azarbarzin, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-10

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2020-09-10

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

Sleep apnea
Hypoxic burden
Arousal intensity
Post-event tachycardia
Positive airway pressure
Apnea hypopnea index

Additional Relevant MeSH Terms

Sleep Apnea