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Not yet recruitingEarly Phase 1

Impacts of Opioids on Respiratory Drive During Sleep

Mechanisms of Opioid-induced Respiratory Depression (OIRD) During Sleep

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how opioids, a type of pain medicine, affect breathing during sleep. It is for healthy people and people with obstructive sleep apnea, which causes breathing to stop and start during sleep.

The investigators are studying the impact that opioids have on breathing during sleep in healthy participants and those diagnosed with obstructive sleep apnea.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Healthy group: A lab sleep test within 3 months before joining must show fewer than 5 breathing pauses or slowdowns per hour.
  • Sleep apnea group: A lab sleep test within 3 months before joining must show more than 10 breathing pauses or slowdowns per hour. People may be treated or untreated.

Who can't join

  • Other sleep-related breathing problems or lung disorders, except obstructive sleep apnea in the sleep apnea group. This includes asthma, COPD (long-term lung disease), breathing pauses mostly caused by missed brain signals, or long-term low breathing or oxygen levels (awake oxygen below 92%).
  • Other sleep disorders: more than 20 repeated limb movements per hour, narcolepsy (sudden sleep attacks), or unusual actions during sleep.
  • Any major health condition that is not stable; unstable heart disease, especially with heart rhythm risks or problems; kidney or liver problems; or untreated or unstable hormone problems, such as thyroid or adrenal gland problems.
  • Medicines that speed up or slow breathing, including opioids taken at home, or medicines that slow brain activity. Medicines that interact with morphine also rule you out, including certain antidepressants such as SSRIs, SNRIs, TCAs, MAOIs, bupropion, and trazodone.
  • Allergy to lidocaine, oxymetazoline, morphine, or other opioids.
  • Pregnancy, breastfeeding, or a history of substance abuse, especially opioid abuse.
  • A blocked stomach or bowel. Constipation alone does not rule you out because morphine is given for only one night.
  • Recent head injury, brain tumors, or other causes of high pressure inside the skull; epilepsy or past seizures; or severe mental health conditions, especially past psychosis (trouble knowing what is real).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

MA