Actively Recruiting
Do Endotypes Predict Response and Sequelae in Obstructive Sleep Apnea Patients
Led by University of California, San Diego · Updated on 2024-10-02
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying why some people develop Obstructive Sleep Apnea (OSA) and how the underlying causes relate to symptoms like sleepiness and high blood pressure. The study aims to understand how these causes affect responses to different treatments such as CPAP, eszopiclone, and supplemental oxygen. This research could help tailor treatment to individuals and understand the problems OSA might cause. Participants will undergo two baseline overnight sleep studies followed by two experimental overnight studies where they receive either 2mg eszopiclone before bedtime or supplemental oxygen at 4 liters per minute via nasal cannula during sleep, in random order. After these studies, participants will either start CPAP therapy immediately with a loaned device for 8 weeks or remain untreated until they receive their prescribed CPAP, which typically takes about 8 weeks. During the 8-week period, researchers will assess various outcomes including vigilance using the Psychomotor Vigilance Test and endothelial function. They will also evaluate neurocognitive function, sleep quality, sleepiness, fatigue, depression, pain, blood pressure, and patient-reported function through questionnaires and scales. The study includes monitoring of these measures to understand treatment responses and OSA effects over time.
CONDITIONS
Brief Title
Do Endotypes Predict Response and Sequelae in OSA Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 21-65 years old
- Men and women with a physician diagnosis of obstructive sleep apnea or strongly suspected to have sleep apnea
- Body mass index (BMI) between 20 and 35 kg/m2
You will not qualify if you...
- Current or planned pregnancy
- Nursing
- Unable to provide self-consent or complete study procedures in English
- Already on effective therapy and adherent for obstructive sleep apnea
- Untreated sleep disorders like periodic limb movement disorder or narcolepsy
- Circadian rhythm disorder
- Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
- Uncontrolled hypertension (systolic >160 or diastolic >95 mm Hg)
- Chronic lung disease requiring supplemental oxygen or with hypercapnia
- Presence of tracheostomy
- Hospitalization within the past 90 days
- Prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding within 5 years
- Prior gastric bypass surgery
- Chronic liver disease or end-stage kidney disease
- Active cancer
- Allergy to any study drug
- Regular use of opioids, sedatives, hypnotics, or theophylline
- Chronic use of eszopiclone
- Active illicit substance use
- Excessive nightly alcohol use (>1 drink for women, >2 for men)
- Active smoking or vaping within past 6 months
- Psychiatric disease except controlled depression/anxiety
- Prisoner status
- Subjects strongly suspected to have sleep apnea will be offered a home sleep apnea test to confirm diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants undergo two initial baseline overnight sleep studies to assess their condition before any treatment.
2 overnight study visits
Duration - 2 weeks
Participants receive two experimental overnight studies in random order with either Eszopiclone (2mg before bedtime) or supplemental oxygen (4L/min via nasal cannula during time in bed).
2 overnight study visits
Duration - 8 weeks
Participants begin CPAP therapy. Those in the Early PAP Start group use a loaner CPAP for 8 weeks immediately, while those in the Usual PAP Start group wait approximately 8 weeks before starting their prescribed CPAP therapy.
Participants have regular CPAP use at home; follow-up visits as prescribed by the study team
Trial Site Locations
Total: 1 location
1
Altman Clinical and Translational Research Institute Building
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
P
Pamela DeYoung
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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