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Tests treatment safety and results for Postoperative Insomnia
Official title Efficacy of Suvorexant on Post-operative Sleep Disturbance
ClinicalTrials.gov ID: NCT05823844
What this study is testing
What is Suvorexant?
Suvorexant is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for postoperative insomnia.
Also referred to as Belsomra.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is a parallel group, double blind, randomized trial. Subjects will be recruited from individuals undergoing elective surgery for orthopedic, abdominal, urologic, gynecologic or spine reasons.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 90
You may be able to join if
- Aged 50 years to 90 years old.
- Patients getting elective surgeries for orthopedic reasons (e.g., hip or knee replacement), abdominal surgery (e.g., hernia repair, renal cancer)...
- Patients experiencing insomnia characterized by difficulties with sleep onset, early morning awakening, and/or sleep maintenance three or more times...
You likely can't join if
- Patients who undergo surgery and then are admitted to intensive care.
- Coronary artery bypass graft (CABG) or other cardiac surgeries.
- Intra-cranial surgery.
- Patients taking more than 60 mg of oxycodone or it's equivalent as outpatient
- Circadian rhythm disorders.
- High score in the Geriatric Depression Scale (GDS)
See the full eligibility criteria
- Aged 50 years to 90 years old.
- Patients getting elective surgeries for orthopedic reasons (e.g., hip or knee replacement), abdominal surgery (e.g., hernia repair, renal cancer), urologic or gynecologic surgery, and spine surgery with a projected...
- Patients experiencing insomnia characterized by difficulties with sleep onset, early morning awakening, and/or sleep maintenance three or more times weekly over a three-month period for eligibility.
- Patients who undergo surgery and then are admitted to intensive care.
- Coronary artery bypass graft (CABG) or other cardiac surgeries.
- Intra-cranial surgery.
- Patients taking more than 60 mg of oxycodone or it's equivalent as outpatient
- Circadian rhythm disorders.
- High score in the Geriatric Depression Scale (GDS)
- Moderate to severe dementia (failed t-MoCa)
- Severe obstructive sleep apnea (OSA) (Apnea-hypopnea index (AHI)\>30 and/or screen high risk)
- Patients receiving Cytochrome P-450 (CYP3) inhibitors or inducers (Inhibitors: clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, and grapefruit. Inducers...
- Vulnerable populations (i.e., children, pregnant women).
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.