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Sleeping pill may boost CPAP use in patients with double trouble

NCT ID NCT06017921

Symptom relief Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a 14-day course of the sleep medication eszopiclone could help people with both insomnia and obstructive sleep apnea use their CPAP machine more consistently. Sixty participants were randomly assigned to receive either eszopiclone or a placebo. The researchers measured CPAP use after 30 days and again after 6 months, along with sleep quality and anxiety levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
eszopiclone (a sleep medication)
What this could lead to
If it works, this could point toward a way to help people with both insomnia and sleep apnea stick with CPAP therapy, improving their sleep and health.
What could go wrong
This is a small, completed phase 4 trial with only 60 participants, so results may not apply to everyone. The sleep aid might not improve CPAP use long-term and could cause side effects like drowsiness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

60 people

The number who actually took part.

Started

Aug 2023

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Clinical diagnosis of Insomnia; * Moderate or severe OSA (AHI ≥ 15 events/h), diagnosed by polysomnography. Exclusion Criteria: * Craniofacial anatomical abnormalities or severe otorhinolaryngological disorders that potentially impair CPAP use; * Use of hypnotics for more than 7 days in the last 2 months; * Renal dysfunction (serum creatinine \>2mg/dL); * Severe liver or cardiac dysfunction; * Alcoholism; * Previous CPAP or mandibular advancement device for OSA treatment in the last 12 months.

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Conditions

The condition(s) this trial relates to.

insomnia obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia Obstructive sleep apnea

Contacts and locations

Locations

  • Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo

    São Paulo, 55, Brazil

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