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New treatment option for Sleep Apnea
Official title Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT07332442
What this study is testing
What is Eszopiclone?
Eszopiclone is an investigational medicine, being studied as a potential treatment for sleep apnea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study design is a randomized, controlled clinical trial to test the hypothesis that arousal threshold (ArTH) will affect how individuals with obstructive sleep apnea (OSA, Apnea-Hypopnea Index (AHI) of 10/hour of higher) respond to CPAP therapy regarding adherence and cognitive function (executive function). Investigators hypothesize that raising ArTH with eszopiclone will improve adherence to CPAP and neurocognitive function with CPAP therapy.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able to provide informed consent.
- Clinically confirmed new diagnosis of OSA:
- Polysomnography AHI ≥ 10 per hour of sleep and/or
- Home sleep apnea testing, respiratory even index, REI ≥ 10 per hour of recording
You likely can't join if
- Known non-OSA related conditions associated with sleep-disordered breathing (e.g., a central disorder of hypersomnolence, neurological...
- Use of sleep-inducing medications (e.g., other non-benzodiazepine sedative hypnotic-drugs [e.g., zoldpidem], benzodiazepines, non-selective...
- Known hypersensitivity reaction to eszopiclone
- Contraindications to its use based on medical history or function (e.g., dizziness at baseline or established mobility problems or imbalance)
- History of complex sleep behaviors (e.g., NREM or REM parasomnias)
- Concomitant use of ≥ 2 servings of alcohol per night or other CNS depressant for 2 weeks prior or throughout the study
See the full eligibility criteria
- Able to provide informed consent.
- Clinically confirmed new diagnosis of OSA:
- Polysomnography AHI ≥ 10 per hour of sleep and/or
- Home sleep apnea testing, respiratory even index, REI ≥ 10 per hour of recording
- Known non-OSA related conditions associated with sleep-disordered breathing (e.g., a central disorder of hypersomnolence, neurological, neuromuscular, or pulmonary disorder)
- Use of sleep-inducing medications (e.g., other non-benzodiazepine sedative hypnotic-drugs [e.g., zoldpidem], benzodiazepines, non-selective antihistamines, trazodone, opiates, barbituates)
- Known hypersensitivity reaction to eszopiclone
- Contraindications to its use based on medical history or function (e.g., dizziness at baseline or established mobility problems or imbalance)
- History of complex sleep behaviors (e.g., NREM or REM parasomnias)
- Concomitant use of ≥ 2 servings of alcohol per night or other CNS depressant for 2 weeks prior or throughout the study
- Sleep opportunity of less than 7 hours
- Severe active depression or other mental health disorders (e.g., schizophrenia, bipolar disorder, personality disorder).
- History of sleep-walking, sleep-driving, and engaging in other activities while not fully awake
- History of motor vehicle accidents related to sleepiness and/or motor vehicle "near misses" (e.g. sleepiness during driving or lane changes)
- Severe hepatic impairment (liver function tests 2 X the upper limit of normal)
- Unstable medical condition (e.g., decompensated heart failure, end-stage chronic obstructive pulmonary disease, end-stage renal disease)
- Females of childbearing potential who are pregnant, breastfeeding, or intend to become pregnant, and women who are in the process of egg donation .
The study team makes the final eligibility decision.
Where it's taking place
- North Haven, Connecticut, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include North Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.