NCT07392840

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Feb 2026Apr 2027

First Submitted

Initial submission to the registry

January 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 31, 2026

Last Update Submit

February 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    Baseline one day before operation

Study Arms (2)

Group A

25 patients with preoperative sleep disorders

Group B

25 patients without preoperative sleep disorders

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Wagner S, Ahrens E, Wachtendorf LJ, et al. Association of obstructive sleep apnea with postoperative delirium in procedures of moderate-to-high complexity: a hospital-registry study. Anesth Analg. 2023.

    BACKGROUND
  • Travica N, Lotfaliany M, Marriott A, et al. Peri-operative risk factors associated with post-operative cognitive dysfunction (POCD): an umbrella review of meta-analyses of observational studies. J Clin Med. 2023;12:1610.

    BACKGROUND
  • POIRIER, Gabriel, et al. Deterioration, compensation and motor control processes in healthy aging, mild cognitive impairment and Alzheimer's disease. Geriatrics, 2021, 6.1: 33

    BACKGROUND
  • Monti JM, Torterolo P, Lagos P. Melanin-concentrating hormone control of sleep-wake behavior. Sleep Med Rev.2013;17:293-298. Nasreddine ZS, Phillips NA, Bedirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53:695-699.

    BACKGROUND
  • Li 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
  • 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;28:193-213.

    BACKGROUND
  • Butris N, Tang E, Pivetta B, et al. The prevalence and risk factors of sleep disturbances in surgical patients:a systematic review and meta-analysis. Sleep Med Rev.2023;69:101786.

    BACKGROUND
  • Nasreddine ZS, Phillips NA, Bedirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53:695-699.

    BACKGROUND
  • Monti JM, Torterolo P, Lagos P. Melanin-concentrating hormone control of sleep-wake behavior. Sleep Med Rev.2013;17:293-298.

    BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Mohamed Mostafa Ali, MD

    El-minya University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Yasein Mohamed, Assistant lecturer

CONTACT

Mohamed Mostafa Ali, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, assistant lecturer anesthesiologist

Study Record Dates

First Submitted

January 31, 2026

First Posted

February 6, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 10, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share