Postoperative Cognitive DysfunctionNCT07392840
Postoperative Cognitive Dysfunction in Elderly and it's Relation With Sleep Disorders and Melanin Concentrating Hormone
An observational study of Postoperative Cognitive Dysfunction, run by Minia University.
Trial summary
The aim of this study is to explore the relationship between preoperative sleep disorders, melanin-concentrating hormone (MCH), and delayed neurocognitive recovery early after surgery in older adult patients undergoing spinal anesthesia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: A total of (50) patients candidate for elective lower limb surgery aged from 65 years of both sexes will be enrolled in this study.
Who may be able to join
- Patients of both genders ageing 65 years or above.
- ASA grade I to III.
- Undergo elective lower limb surgery under spinal anesthesia
- Agree to collect one's own CSF and blood samples
Who cannot join
- Past history of depression,anxiety,delirium and schizophrenia .
- Past history of drug dependence.
- Past history of dementia,including Alzheimer disease(AD).
- Preoperative Montreal Cognitive Assessment (MoCA) score <26.
- Inability to understand or cooperate with the evaluation scale or questionnaire.
- Refuse collecting one's own CSF and blood samples.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Postoperative Delayed Neurocognitive Recovery in Elderly Patients Undergoing Spinal Anesthesia: Assessment of Its Prevalence and Correlation With Preoperative Sleep Disorders and Melanin Concentrating Hormone.
The aim of this study is to explore the relationship between preoperative sleep disorders, melanin-concentrating hormone (MCH), and delayed neurocognitive recovery early after surgery in older adult patients undergoing spinal anesthesia.
Read the detailed description
Perioperative neurocognitive disorders (PNDs) have gradually become a priority during the perioperative period, including neurocognitive disorder before surgery, delirium and delayed neurocognitive recovery (DNR) within 30 days after surgery, and postoperative neurocognitive disorder up to 12 months after surgery. The incidence of DNR ranges from 9.1% to 45%, which seriously affects the perioperative brain health of older adult patients .
The increasing aging population and the reduced function and compensatory capacity of various systems in elderly patients also significantly increase the risk of cognitive dysfunction .
Sleep disorders are critical risk factors among the various risk factors for DNR after surgery. Meanwhile, aging is an independent risk factor for sleep disorders .
Therefore, it is clinically significant to conduct early cognitive risk prediction, focusing on older adult patients with preoperative sleep disorders. Studies have explored the risk factors for perioperative sleep disorders, while other studies have also explored the risk factors affecting postoperative cognitive outcomes. However, no study has explored the specific risk factors for DNR in patients with preoperative sleep disorders. Considering the relationship between sleep and postoperative cognitive function, especially in older adult patients, it is necessary to link these 2 main risk factors (preoperative sleep disorders and DNR) that impair the perioperative brain health to explore potential biomarkers .
Melanin-concentrating hormone (MCH) is a highly conserved cyclic neuropeptide with 19 amino acids in mammals and has a variety of physiological functions, including orexigenic properties, energy homeostasis, regulation of moods, sleep, wakefulness, and cognitive functions .
Melanin-concentrating hormone (MCH) can enhance synaptic plasticity in the hippocampus, which plays an important role in maintaining cognitive function In addition to regulating synaptic plasticity, MCH can also regulate cognitive functions such as learning and memory by regulating rapid eye movement (REM) sleep and acetylcholine outflow in the hippocampus .
- Conditions
- Postoperative Cognitive Dysfunction
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 25 patients with preoperative sleep disorders | |
| Group B | 25 patients without preoperative sleep disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the impact of preoperative sleep problems as indicators of delayed neurocognitive recovery (DNR) in elderly adults following spinal anesthesia.
By comparison between the two groups
Measured: Baseline, one week, three months
Secondary outcomes (1)
to investigate the predictive power of CSF and plasma MCH levels for delayed neurocognitive recovery (DNR) in older adults after spinal anesthesia
Measured: Baseline one day before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Yasein Mohamed Moawad, Minia University
- Investigators
- Mohamed Mostafa Ali, MD, Principal investigator, El-minya University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392840
- Sponsor's protocol ID
- Postop. cognitive dysfunction
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wagner S, Ahrens E, Wachtendorf LJ, Suleiman A, Tartler TM, Shay D, Azimaraghi O, Munoz-Acuna R, Chen G, Ma H, Eikermann M, Schaefer MS. Association of Obstructive Sleep Apnea With Postoperative Delirium in Procedures of Moderate-to-High Complexity: A Hospital-Registry Study. Anesth Analg. 2024 Mar 1;138(3):626-634. doi: 10.1213/ANE.0000000000006425. Epub 2023 Mar 30.
PubMed 36995964Travica N, Lotfaliany M, Marriott A, Safavynia SA, Lane MM, Gray L, Veronese N, Berk M, Skvarc D, Aslam H, Gamage E, Formica M, Bishop K, Marx W. Peri-Operative Risk Factors Associated with Post-Operative Cognitive Dysfunction (POCD): An Umbrella Review of Meta-Analyses of Observational Studies. J Clin Med. 2023 Feb 17;12(4):1610. doi: 10.3390/jcm12041610.
PubMed 36836145Poirier G, Ohayon A, Juranville A, Mourey F, Gaveau J. Deterioration, Compensation and Motor Control Processes in Healthy Aging, Mild Cognitive Impairment and Alzheimer's Disease. Geriatrics (Basel). 2021 Mar 23;6(1):33. doi: 10.3390/geriatrics6010033.
PubMed 33807008Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Li Yun,Zhang Xizhe, et al . Research progress on the role of melanin-concentrating hormone system in sleep deprivation -induced impairment of learning and memory function [ J ] . International Journal of Anesthesiology and Resuscitation , 2022 , 43 ( 10 ): 1117-1120 .
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Butris N, Tang E, Pivetta B, He D, Saripella A, Yan E, Englesakis M, Boulos MI, Nagappa M, Chung F. The prevalence and risk factors of sleep disturbances in surgical patients: A systematic review and meta-analysis. Sleep Med Rev. 2023 Jun;69:101786. doi: 10.1016/j.smrv.2023.101786. Epub 2023 Apr 19.
PubMed 37121133Monti JM, Torterolo P, Lagos P. Melanin-concentrating hormone control of sleep-wake behavior. Sleep Med Rev. 2013 Aug;17(4):293-8. doi: 10.1016/j.smrv.2012.10.002. Epub 2013 Mar 9.
PubMed 23477948
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Delayed Neurocognitive Recovery in Elderly Patients Undergoing Spinal Anesthesia: Assessment of Its Prevalence and Correlation With Preoperative Sleep Disorders and Melanin Concentrating Hormone.
- ClinicalTrials.gov ID
- NCT07392840
- Acronym / sponsor ID
- Postop. cognitive dysfunction
- Conditions
- Postoperative Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 6 Feb 2026 (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.
The aim of this study is to explore the relationship between preoperative sleep disorders, melanin-concentrating hormone (MCH), and delayed neurocognitive recovery early after surgery in older adult patients undergoing spinal anesthesia.
Detailed description
Perioperative neurocognitive disorders (PNDs) have gradually become a priority during the perioperative period, including neurocognitive disorder before surgery, delirium and delayed neurocognitive recovery (DNR) within 30 days after surgery, and postoperative neurocognitive disorder up to 12 months after surgery. The incidence of DNR ranges from 9.1% to 45%, which seriously affects the perioperative brain health of older adult patients .
The increasing aging population and the reduced function and compensatory capacity of various systems in elderly patients also significantly increase the risk of cognitive dysfunction .
Sleep disorders are critical risk factors among the various risk factors for DNR after surgery. Meanwhile, aging is an independent risk factor for sleep disorders .
Therefore, it is clinically significant to conduct early cognitive risk prediction, focusing on older adult patients with preoperative sleep disorders. Studies have explored the risk factors for perioperative sleep disorders, while other studies have also explored the risk factors affecting postoperative cognitive outcomes. However, no study has explored the specific risk factors for DNR in patients with preoperative sleep disorders. Considering the relationship between sleep and postoperative cognitive function, especially in older adult patients, it is necessary to link these 2 main risk factors (preoperative sleep disorders and DNR) that impair the perioperative brain health to explore potential biomarkers .
Melanin-concentrating hormone (MCH) is a highly conserved cyclic neuropeptide with 19 amino acids in mammals and has a variety of physiological functions, including orexigenic properties, energy homeostasis, regulation of moods, sleep, wakefulness, and cognitive functions .
Melanin-concentrating hormone (MCH) can enhance synaptic plasticity in the hippocampus, which plays an important role in maintaining cognitive function In addition to regulating synaptic plasticity, MCH can also regulate cognitive functions such as learning and memory by regulating rapid eye movement (REM) sleep and acetylcholine outflow in the hippocampus .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –25 patients with preoperative sleep disorders |
| Group B | – | –25 patients without preoperative sleep disorders |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- A total of (50) patients candidate for elective lower limb surgery aged from 65 years of both sexes will be enrolled in this study.
Key inclusion criteria (4 listed)
- Patients of both genders ageing 65 years or above.
- ASA grade I to III.
- Undergo elective lower limb surgery under spinal anesthesia
- Agree to collect one's own CSF and blood samples
Key exclusion criteria (6 listed)
- Past history of depression,anxiety,delirium and schizophrenia .
- Past history of drug dependence.
- Past history of dementia,including Alzheimer disease(AD).
- Preoperative Montreal Cognitive Assessment (MoCA) score <26.
- Inability to understand or cooperate with the evaluation scale or questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate the impact of preoperative sleep problems as indicators of delayed neurocognitive recovery (DNR) in elderly adults following spinal anesthesia.
Time frame: Baseline, one week, three months
By comparison between the two groups
1 secondary outcome
to investigate the predictive power of CSF and plasma MCH levels for delayed neurocognitive recovery (DNR) in older adults after spinal anesthesia
Time frame: Baseline one day before operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 36995964Wagner S, Ahrens E, Wachtendorf LJ, Suleiman A, Tartler TM, Shay D, Azimaraghi O, Munoz-Acuna R, Chen G, Ma H, Eikermann M, Schaefer MS. Association of Obstructive Sleep Apnea With Postoperative Delirium in Procedures of Moderate-to-High Complexity: A Hospital-Registry Study. Anesth Analg. 2024 Mar 1;138(3):626-634. doi: 10.1213/ANE.0000000000006425. Epub 2023 Mar 30.
- Background: PubMed 36836145Travica N, Lotfaliany M, Marriott A, Safavynia SA, Lane MM, Gray L, Veronese N, Berk M, Skvarc D, Aslam H, Gamage E, Formica M, Bishop K, Marx W. Peri-Operative Risk Factors Associated with Post-Operative Cognitive Dysfunction (POCD): An Umbrella Review of Meta-Analyses of Observational Studies. J Clin Med. 2023 Feb 17;12(4):1610. doi: 10.3390/jcm12041610.
- Background: PubMed 33807008Poirier G, Ohayon A, Juranville A, Mourey F, Gaveau J. Deterioration, Compensation and Motor Control Processes in Healthy Aging, Mild Cognitive Impairment and Alzheimer's Disease. Geriatrics (Basel). 2021 Mar 23;6(1):33. doi: 10.3390/geriatrics6010033.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- BackgroundLi Yun,Zhang Xizhe, et al . Research progress on the role of melanin-concentrating hormone system in sleep deprivation -induced impairment of learning and memory function [ J ] . International Journal of Anesthesiology and Resuscitation , 2022 , 43 ( 10 ): 1117-1120 .
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 37121133Butris N, Tang E, Pivetta B, He D, Saripella A, Yan E, Englesakis M, Boulos MI, Nagappa M, Chung F. The prevalence and risk factors of sleep disturbances in surgical patients: A systematic review and meta-analysis. Sleep Med Rev. 2023 Jun;69:101786. doi: 10.1016/j.smrv.2023.101786. Epub 2023 Apr 19.
- Background: PubMed 23477948Monti JM, Torterolo P, Lagos P. Melanin-concentrating hormone control of sleep-wake behavior. Sleep Med Rev. 2013 Aug;17(4):293-8. doi: 10.1016/j.smrv.2012.10.002. Epub 2013 Mar 9.
- 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.
Mohamed Mostafa Ali, MD principal investigator
El-minya University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction, run by Minia University.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Yasein Mohamed, Assistant lecturer (+20 01016383701, myasein76@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the impact of preoperative sleep problems as indicators of delayed neurocognitive recovery (DNR) in elderly adults following spinal anesthesia. (time frame: Baseline, one week, three months). 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 NCT07392840, which also lists 8 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 10 Feb 2026.