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Obstructive Sleep ApneaPhase 2TOP-CPAPNCT05951023

Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP)

A Phase 2 study testing Eszopiclone 2 mg in people with Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

More than 10% of the US population have obstructive sleep apnea (OSA). Standard of care is therapy with CPAP (continuous positive airway pressure) which virtually eliminates OSA. However, most patients use CPAP only for part of the night (4-5hours) and about 50% patients discontinue CPAP long-term. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Eszopiclone 2 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteUnited States
Study dates
31 Aug 2023to 1 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • "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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UC San Diego; Altman Clinical and Translational Research Institute Building

    La Jolla, California, 92121

Other trials in United States

About this study

Official title: Endotype-Targeted Therapy to Rescue OSA Patients Struggling With CPAP Adherence (TOP-CPAP): a Pilot Trial

More than 10% of the US population have obstructive sleep apnea (OSA). Standard of care is therapy with CPAP (continuous positive airway pressure) which virtually eliminates OSA. However, most patients use CPAP only for part of the night (4-5hours) and about 50% patients discontinue CPAP long-term. Alternative therapies are limited, thus many OSA patients remain at risk of OSA sequelae (e.g. sleepiness, memory issues, high blood pressure, etc.). Importantly, different patients get OSA for different reasons, and recent data show that some of the underlying causes of OSA ("endotypes") such as having a low arousal threshold (i.e. waking up easily) are associated with lower CPAP adherence. Using a randomized controlled trial design, this will be the first study using a targeted intervention to manipulate the underlying OSA causes (i.e., giving a safe hypnotic to patients with OSA to increase the arousal threshold) to test the hypothesis that endotype-targeted therapy increases CPAP-adherence in patients who have low but continued CPAP usage. Ultimately, this strategy may improve the care and outcomes of millions of undertreated OSA patients.

Read the 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).

Being tested
Eszopiclone 2 mg, Placebo
Keywords
Obstructive Sleep Apnea, OSA, Continuous Positive Airway Pressure, CPAP, Adherence, Eszopiclone, Endotype, Arousal Threshold
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eszopiclone 2 mgDrug

    Also called Lunesta

    Eszopiclone tablet (encapsulated)

  • PlaceboDrug

    Sugar capsule manufactured to match encapsulated Eszopiclone

Study groups in NCT05951023
Study groupRoleWhat they receive
EszopicloneExperimentalSubjects will be asked to take their study drugs nightly at bedtime and use their CPAP during sleep as much as possible
Receives: Drug: Eszopiclone 2 mg
PlaceboPlacebo comparatorSubjects will be asked to take their study drugs nightly at bedtime and use their CPAP during sleep as much as possible
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean use per night of continuous positive airway pressure (CPAP)

    Based on device recorded usage

    Measured: days 2-14 after initiation of study drugs

Secondary outcomes (8)

  1. Alternative measures of CPAP usage

    E.g. percentage of nights with CPAP >4h

    Measured: days 2-14 after initiation of study drugs

  2. Response Speed

    Based on 10-minute Psychomotor vigilance task (PVT)

    Measured: days 2-14 after initiation of study drugs

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SDA) instrument

    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.

    Measured: days 2-14 after initiation of study drugs

  4. Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment (SRI) instrument

    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.

    Measured: days 2-14 after initiation of study drugs

  5. Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument

    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.

    Measured: days 2-14 after initiation of study drugs

  6. Epworth Sleepiness Scale (ESS)

    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.

    Measured: days 2-14 after initiation of study drugs

  7. Apnea Hypopnea Index

    The AHI is a measure of sleep apnea severity and is defined as the number of apneas and hypopneas per hour of sleep.

    Measured: day1 of study drugs

  8. Mean Blood Pressure (mmHg)

    Average of two in-office blood pressure measurements

    Measured: day 14 after initiation of study drugs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2023
  2. Study start31 Aug 2023
  3. Primary completion23 Jul 2025
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, placebo-controlled, parallel trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951023
Sponsor's protocol ID
190560
Other IDs
277-JF-22
Acronym
TOP-CPAP
Status last verified
Nov 2025
First submitted
17 Jun 2023
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eszopiclone 2 mg in people with Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean use per night of continuous positive airway pressure (CPAP) (time frame: days 2-14 after initiation of study drugs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05951023.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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