InsomniaNCT05664295
Orexin-A Levels in Insomnia Patients
An observational study of Insomnia and Anesthesia, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
In the pathophysiology of insomnia, the increase of the orexin-A (OXA) peptide released from orexin neurons in the lateral hypothalamus plays an important role. Orexins takes part at the emergence of anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Anesthesia
- What is being tested?
- Jenkins Sleep Disorders scale and Epworth Sleepiness scale
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2022to 10 Feb 2023
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male patients undergo elective laparoscopic cholecystectomy under general anesthesia
Who may be able to join
- male patients undergo elective laparoscopic cholecystectomy under general anesthesia
- Between 18-65 age
- ASA I-II
Who cannot join
- ASA≥III
- Patients with obstructive sleep apnea syndrome
- Bleeding over 500 ml
- Allergic to anesthetic agents
- Patients with a BMI > 30 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Plasma Orexin-A Levels and Awakening Time From Anesthesia in Patients With and Without Insomnia Who Had Laparoscopic Cholecystectomy Under General Anesthesia
In the pathophysiology of insomnia, the increase of the orexin-A (OXA) peptide released from orexin neurons in the lateral hypothalamus plays an important role. Orexins takes part at the emergence of anesthesia. In the literature, investigators could not attain any studies about the arousal of insomnia patients from anesthesia. In this study, the effect of this peptide on the emergence process from anesthesia was investigated by comparing plasma OXA levels before and after anesthesia in insomnia patients.
Read the detailed description
ASA (American Society of Anesthesiologists) I-II patients aged 18-65 years who underwent elective laparoscopic cholecystectomy were included in the study. Patients were evaluated with the Jenkins Sleep Disorders scale and Epworth Sleepiness scale during preoperative examination and were divided into insomnia and control groups. Blood samples were obtained for OXA and glucose levels at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation. The times from stopping anesthesia to eyes opening and extubation and end-tidal sevoflurane concentrations at these time points were recorded.
- Conditions
- Insomnia, Anesthesia
- Being tested
- Jenkins Sleep Disorders scale and Epworth Sleepiness scale
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jenkins Sleep Disorders scale and Epworth Sleepiness scaleDiagnostic test
Jenkins Sleep Disorders scale and Epworth Sleepiness scale
| Study group | Role | What they receive |
|---|---|---|
| insomnia patients | Jenkins Sleep Disorders scale skor >1 and Epworth Sleepiness scale skor >9 Receives: Diagnostic Test: Jenkins Sleep Disorders scale and Epworth Sleepiness scale | |
| noninsomniacs | Jenkins Sleep Disorders scale skor <2 and Epworth Sleepiness scale skor <10 Receives: Diagnostic Test: Jenkins Sleep Disorders scale and Epworth Sleepiness scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orexin-A Levels
plasma OXA levels anesthesia induction and after anesthesia in insomnia patients
Measured: at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation
Orexin-A Levels
plasma OXA levels anesthesia induction and after anesthesia in control group
Measured: at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation
Secondary outcomes (1)
recovery time from general anesthesia
The relationship between plasma OXA levels and recovery times from anesthesia in insomnia patients
Measured: time of eyes opening and time of extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start30 Dec 2022
- Primary completion30 Jan 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melike Korkmaz Toker, Muğla Sıtkı Koçman University
- Investigators
- melike Korkmaz Toker, Principal investigator, Mugla Sıtkı Kocman University Department of Anesthesiology and reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664295
- Sponsor's protocol ID
- 14/III
- Status last verified
- Mar 2023
- First submitted
- 21 Nov 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bollu PC, Kaur H. Sleep Medicine: Insomnia and Sleep. Mo Med. 2019 Jan-Feb;116(1):68-75.
PubMed 30862990Hirota K. [Orexinergic neurons and noradrenergic awakening system in general anesthesia]. Masui. 2007 Jan;56(1):9-18. Japanese.
PubMed 17243641Erden V, Abitagaoglu S, Guler C, Dogan Z, Kirgezen S, Abut Y. Insomnia may increase anesthetic requirement. J Clin Anesth. 2016 Nov;34:367-72. doi: 10.1016/j.jclinane.2016.05.020. Epub 2016 Jun 4. No abstract available.
PubMed 27687412
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plasma Orexin-A Levels and Awakening Time From Anesthesia in Patients With and Without Insomnia Who Had Laparoscopic Cholecystectomy Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05664295
- Acronym / sponsor ID
- 14/III
- Conditions
- Insomnia, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the pathophysiology of insomnia, the increase of the orexin-A (OXA) peptide released from orexin neurons in the lateral hypothalamus plays an important role. Orexins takes part at the emergence of anesthesia. In the literature, investigators could not attain any studies about the arousal of insomnia patients from anesthesia. In this study, the effect of this peptide on the emergence process from anesthesia was investigated by comparing plasma OXA levels before and after anesthesia in insomnia patients.
Detailed description
ASA (American Society of Anesthesiologists) I-II patients aged 18-65 years who underwent elective laparoscopic cholecystectomy were included in the study. Patients were evaluated with the Jenkins Sleep Disorders scale and Epworth Sleepiness scale during preoperative examination and were divided into insomnia and control groups. Blood samples were obtained for OXA and glucose levels at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation. The times from stopping anesthesia to eyes opening and extubation and end-tidal sevoflurane concentrations at these time points were recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insomnia patients | – | Diagnostic Test: Jenkins Sleep Disorders scale and Epworth Sleepiness scaleJenkins Sleep Disorders scale skor >1 and Epworth Sleepiness scale skor >9 |
| noninsomniacs | – | Diagnostic Test: Jenkins Sleep Disorders scale and Epworth Sleepiness scaleJenkins Sleep Disorders scale skor <2 and Epworth Sleepiness scale skor <10 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients undergo elective laparoscopic cholecystectomy under general anesthesia
Key inclusion criteria (3 listed)
- male patients undergo elective laparoscopic cholecystectomy under general anesthesia
- Between 18-65 age
- ASA I-II
Key exclusion criteria (5 listed)
- ASA≥III
- Patients with obstructive sleep apnea syndrome
- Bleeding over 500 ml
- Allergic to anesthetic agents
- Patients with a BMI > 30 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jenkins Sleep Disorders scale and Epworth Sleepiness scaleJenkins Sleep Disorders scale and Epworth Sleepiness scale | Diagnostic test | insomnia patients, noninsomniacs |
Primary outcome
Orexin-A Levels
Time frame: at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation
plasma OXA levels anesthesia induction and after anesthesia in insomnia patients
Orexin-A Levels
Time frame: at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation
plasma OXA levels anesthesia induction and after anesthesia in control group
1 secondary outcome
recovery time from general anesthesia
Time frame: time of eyes opening and time of extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 30862990Bollu PC, Kaur H. Sleep Medicine: Insomnia and Sleep. Mo Med. 2019 Jan-Feb;116(1):68-75.
- Background: PubMed 17243641Hirota K. [Orexinergic neurons and noradrenergic awakening system in general anesthesia]. Masui. 2007 Jan;56(1):9-18. Japanese.
- Background: PubMed 27687412Erden V, Abitagaoglu S, Guler C, Dogan Z, Kirgezen S, Abut Y. Insomnia may increase anesthetic requirement. J Clin Anesth. 2016 Nov;34:367-72. doi: 10.1016/j.jclinane.2016.05.020. Epub 2016 Jun 4. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
melike Korkmaz Toker principal investigator
Mugla Sıtkı Kocman University Department of Anesthesiology and reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia and Anesthesia, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orexin-A Levels (time frame: at anesthesia induction, 5 minutes after extubation and 30 minutes after extubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05664295, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.