- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05951023
Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP) (TOP-CPAP)
Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP): a Pilot Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This double-blind, randomized, placebo-controlled, single-center, phase II trial, will test if endotype-targeted drug therapy increases CPAP adherence. Patients with low CPAP adherence (i.e. CPAP use 0.5-4h/night) will be randomized in parallel to CPAP+Eszopiclone vs CPAP+Placebo for 2 weeks. The primary outcome is mean TimeOnCPAP/night on days 2-14 after initiation of study drugs.
Aim 1: To test the effect of eszopiclone on CPAP usage in unselected OSA patients with low CPAP adherence.
Hypothesis 1: Eszopiclone improves CPAP usage more than placebo.
Aim 2: To test the effect of eszopiclone on CPAP usage in OSA patients with a low vs a high arousal threshold (ArTH) endotype.
Hypothesis 2: Eszopiclone improves CPAP usage substantially more in OSA patients with a low vs a high ArTH.
Further, this study will explore the mechanisms through which eszopiclone may affect CPAP usage, the effect of eszopiclone on underlying sleep apnea severity, and if the intervention and its potential effects on adherence translate into changes in clinically important outcomes (i.e., vigilance and sleepiness).
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Pamela DeYoung, RPSGT
- Phone Number: 858 246 2183
- Email: sleepresearch@health.ucsd.edu
Study Locations
-
-
California
-
La Jolla, California, United States, 92121
- Recruiting
- UC San Diego; Altman Clinical and Translational Research Institute Building
-
Contact:
- Pamela DeYoung, RPSGT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 21-65 years old
- Body Mass Index <32 kg/m^2
- Physician diagnosis of OSA (AHI ≥ 10) based on a clinical sleep study within the past 2 years (subjects who report a history of sleep apnea but do not have a sleep study report from the past 2 years available will be offered an overnight home sleep apnea test to verify OSA diagnosis)
- AHI>5/h on the overnight research sleep study #1
- Subject had the opportunity to use CPAP for at least 1 month
- Continuous positive airway pressure (CPAP) data can be queried remotely and shows usage 0.5-4h/night (based on most recent 30 day period)
- Interest to continue trying CPAP
Exclusion Criteria:
- "SAVE CPAP Side Effect Score" >3 (1 point for each: dry mouth, nasal symptoms, CPAP pressure intolerance, claustrophobia, noise problems, soreness/skin irritation, mask fit/leak problems)
- Any high-risk features: Epworth sleepiness score ≥18, safety-critical profession (e.g., commercial driver), prior sleep-related car accident, substantial hypoxemia during sleep [SpO2<70% for >5min] or awake [SpO2<92%]
- Any uncontrolled medical/psychiatric condition, or safety concern based on MD judgment
- Pregnancy/Breastfeeding (current or planned during the next month)
- Inability to complete study procedures, such as questionnaires that are only available/validated in English
- Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy
- Unwilling or unable to withhold CPAP during polysomnography
- Presence of tracheostomy
- Hospitalization within the past 90 days
- Allergy to the study drug
- Regular use of opioids, or benzodiazepines
- Chronically using study drug or other hypnotic
- Significant circadian rhythm disorder or sleepwalking as an adult
- Active illicit substance use or >3 oz nightly alcohol use
- Prisoners
- Cognitive impairment, unable to provide consent, or unable to carry out research procedures
- Safety concern based on MD judgment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eszopiclone
Subjects will be asked to take their study drugs nightly at bedtime and use their CPAP during sleep as much as possible
|
Eszopiclone tablet (encapsulated)
Other Names:
|
Placebo Comparator: Placebo
Subjects will be asked to take their study drugs nightly at bedtime and use their CPAP during sleep as much as possible
|
Sugar capsule manufactured to match encapsulated Eszopiclone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean use per night of continuous positive airway pressure (CPAP)
Time Frame: days 2-14 after initiation of study drugs
|
Based on device recorded usage
|
days 2-14 after initiation of study drugs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alternative measures of CPAP usage
Time Frame: days 2-14 after initiation of study drugs
|
E.g. percentage of nights with CPAP >4h
|
days 2-14 after initiation of study drugs
|
Response Speed
Time Frame: days 2-14 after initiation of study drugs
|
Based on 10-minute Psychomotor vigilance task (PVT)
|
days 2-14 after initiation of study drugs
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SDA) instrument
Time Frame: days 2-14 after initiation of study drugs
|
Based on response pattern scoring, the PROMIS 8-item SDA score will be converted into a T-score with a mean of 50 (reflecting the average for the United States general population) and a standard deviation of 10.
Higher t-scores reflect greater sleep disturbance.
|
days 2-14 after initiation of study drugs
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment (SRI) instrument
Time Frame: days 2-14 after initiation of study drugs
|
Based on response pattern scoring, the PROMIS 8-item SRI score will be converted into a T-score with a mean of 50 (reflecting the average for the United States general population) and a standard deviation of 10.
Higher t-scores reflect greater sleep-related impairment.
|
days 2-14 after initiation of study drugs
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument
Time Frame: days 2-14 after initiation of study drugs
|
Based on response pattern scoring, the PROMIS 8-item Fatigue score will be converted into a T-score with a mean of 50 (reflecting the average for the United States general population) and a standard deviation of 10.
Higher t-scores reflect greater sleep-related impairment.
|
days 2-14 after initiation of study drugs
|
Epworth Sleepiness Scale (ESS)
Time Frame: days 2-14 after initiation of study drugs
|
The ESS is an 8-item instrument assessing the likelihood of dozing off in 8 different situations with points for each item ranging from 0 to 3 (0 = would never doze off; 3 = high chance of dozing off).
The points for each item are summed up, thus the total score ranges from 0 to 24, with higher ESS scores indicating greater sleepiness.
|
days 2-14 after initiation of study drugs
|
Apnea Hypopnea Index
Time Frame: day1 of study drugs
|
The AHI is a measure of sleep apnea severity and is defined as the number of apneas and hypopneas per hour of sleep.
|
day1 of study drugs
|
Mean Blood Pressure (mmHg)
Time Frame: day 14 after initiation of study drugs
|
Average of two in-office blood pressure measurements
|
day 14 after initiation of study drugs
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Apnea Traits with special focus on arousal threshold
Time Frame: day1 of study drugs
|
Quantified from routine polysomnography data.
|
day1 of study drugs
|
Average total sleep time per night
Time Frame: days 2-14 after initiation of study drugs
|
Based on actigraphy
|
days 2-14 after initiation of study drugs
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christopher N Schmickl, MD, PhD, University of California, San Diego
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190560
- 277-JF-22 (Other Grant/Funding Number: American Academy of Sleep Medicine Foundation (AASMF))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
-
Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
-
ApnimedCompletedOSA - Obstructive Sleep ApneaUnited States
Clinical Trials on Eszopiclone 2 mg
-
Eisai Co., Ltd.Completed
-
Eisai Co., Ltd.Completed
-
University of Medicine and Dentistry of New JerseySunovionCompletedParkinson's Disease | InsomniaUnited States
-
Eisai Co., Ltd.Completed
-
University of Sao Paulo General HospitalRecruitingInsomnia | Obstructive Sleep ApneaBrazil
-
Dr. Reddy's Laboratories LimitedCompleted
-
SunovionCompleted
-
Laboratorios Andromaco S.A.Completed
-
Dr. Reddy's Laboratories LimitedCompleted
-
University of California, Los AngelesNational Heart, Lung, and Blood Institute (NHLBI)Recruiting