Opioid breathing risks during sleep under the microscope
NCT ID NCT06854211
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will give a single dose of morphine or a placebo to 26 adults (some healthy, some with obstructive sleep apnea) during a sleep study night. Researchers will measure how much their breathing changes. The goal is to understand why opioids can dangerously slow breathing during sleep, especially in people with sleep apnea.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Morphine
- What this could lead to
- If successful, this study could help explain why opioids sometimes cause dangerous breathing problems during sleep, potentially leading to safer pain management guidelines.
- What could go wrong
- This is a very small, early-phase study (26 people) that only looks at breathing changes, not long-term safety or outcomes. Results may not apply to everyone.
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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jul 2026
An estimate. Start dates often move.
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- 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 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Healthy controls: Apnea Hypopnea Index (AHI) \< 5 events/hr on in-laboratory PSG within 3 months of enrollment * OSA group: AHI \> 10 events/hr on in-laboratory PSG within 3 months of enrollment; treated or untreated. Exclusion Criteria: * Sleep disordered breathing or respiratory disorders (other than OSA in the OSA group), such as central sleep apnea (\>50% of respiratory events scored as central), chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions. * Other sleep disorders: periodic limb movements (periodic limb movement index \> 20/hr), narcolepsy, or parasomnias. * Any unstable major medical condition. * Medications expected to stimulate or depress respiration (including other opioids taken at home, barbiturates, benzodiazepines, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid). * History of allergy to lidocaine or oxymetazoline. * Contraindications for morphine, including: * allergy to morphine or opioids * chronic obstructive pulmonary disease, asthma, or other significant respiratory disorders * kidney or liver dysfunction, as this can affect the metabolism and excretion of morphine, leading to increased risk of toxicity. * women who are pregnant or breastfeeding will be excluded due to potential risks to the fetus or infant. * history of substance abuse, particularly opioid abuse, will be excluded to prevent potential misuse or relapse. * current use of central nervous system depressants. * individuals with gastrointestinal obstruction. Constipation is not an exclusion criterion because morphine is only administered for one night. * recent head injury, brain tumors, or other conditions leading to increased intracranial pressure. * unstable heart disease, particularly those with risk factors for or a history of heart rhythm disorders. * epilepsy or a history of seizures, as morphine can lower the seizure threshold. * severe psychiatric conditions, particularly those with a history of psychosis, as opioids can exacerbate these conditions. * medications that interact with morphine, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), Monoamine oxidase inhibitors (MAOIs), and the atypical antidepressants buproprion and trazodone. * untreated or unstable endocrine disorders like adrenal insufficiency or thyroid dysfunction.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Obstructive sleep apnea (OSA) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New mask aims to make sleep apnea therapy easier to live with
- Can a weekly phone call keep sleep apnea patients on CPAP?
- A smart neck brace may replace CPAP for sleep apnea
- A phone app takes on the opioid crisis in high-risk workplaces
- A blood test for liver trouble may flag hidden risk in sleep apnea patients
- Blood oxygen dips may reveal who stays on CPAP