- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07829055
Effects of Mental Tasks on Breathing Patterns in Adults Using Chronic Opioids vs Non-opioid Users. (AWAKE)
Control of Ventilation During Wakefulness in Opioid vs. Non-opioid Patients
The goal of this observational study is to find out if using your brain for a mental task changes how you breathe. Researchers want to compare three groups of adults: people who take opioid pain medicine every day, people with sleep apnea, and healthy people with neither condition. The main questions this study aims to answer are:
- Does breathing change differently during mental tasks in people who take opioids, people with sleep apnea, and healthy controls?
- Is the connection between brain activity and breathing disrupted more in people who use chronic opioids or have OSA, compared with healthy controls, during periods of mental effort?
Researchers will compare the three groups to see if opioid use or sleep apnea makes breathing less steady, or weakens the link between the brain and breathing, when a person is concentrating on a task.
Participants will visit the UC San Diego Sleep Laboratory one time. During the visit, they will:
- Answer questions about sleep, opioid use, and sleep apnea risk.
- Have sensors placed on their skin and scalp to measure brain waves, breathing, and oxygen levels. This is the same kind of equipment used in a regular sleep study, and it does not hurt.
- Sit quietly and rest while their breathing and brain waves are recorded.
- Do a series of short mental tasks on a computer, tablet, or paper, testing things like memory, attention, and thinking speed, while their breathing and brain waves continue to be recorded.
No medicine or treatment will be given during the study, and no blood or other samples will be collected. This study only involves watching and measuring, not testing any treatment.
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
-
-
California
-
San Diego, California, Verenigde Staten, 92037
- University of California San Diego
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria
All participants
- Able to provide informed consent
- Able to communicate in English, see/hear task stimuli (with usual corrective devices), follow multistep instructions, and complete a brief cognitive-task practice example
Opioid group
- Daily prescribed opioid use, under medical supervision, for chronic non-cancer pain, for ≥3 months
- Prescribed dose ≥20 MME/day (no upper limit)
- Stable dose for ≥2 weeks
OSA group
- Diagnosed OSA with AHI ≥15 events/hour (documented on a prior clinical sleep study)
Healthy control group
- No history of chronic prescribed opioid use
- No known history/diagnosis of OSA
- If a prior sleep study exists, AHI must be <10 events/hour within the past 3 years
Exclusion criteria
- Prisoners
- Pregnancy
- BMI <20 or >35
- Unable/unwilling to give informed consent or comply with study procedures
- Significant comorbidities of other organ systems (e.g., chronic kidney disease, CHF/active cardiac symptoms, cirrhosis, severe lung disease)
- Diseases affecting respiratory muscles or breathing control (neuromuscular, neurodegenerative, congenital)
- Psychiatric disease other than controlled mood disorders
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Gezonde controlegroep
|
|
Obstructieve slaapapneu
|
|
Opioid Use
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Respiratory pattern changes during standardized cognitive load tasks
Tijdsspanne: 2 hours
|
2 hours
|
|
|
Respiratory variability/irregularity
Tijdsspanne: 2 hours
|
Measured from breathing signals (nasal pressure/airflow, thoracoabdominal effort belts, end-tidal CO2) during cognitive tasks vs. baseline
|
2 hours
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
EEG-respiratory coupling
Tijdsspanne: 2 hours
|
cortical-respiratory coupling - the degree of association between EEG activity and respiratory signal timing
|
2 hours
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Jeremy Orr, MD, UC San Diego
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 815022
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .