Neurofeedback Training (NFT) on Sleep Quality and Cognitive Function Performance Among HIV-infected Persons

HIV Infections Clinical Trial

Official title:

Construction and Evaluation of Neurofeedback Training (NFT) on Sleep Quality and Cognitive Function Performance Among HIV-infected Persons

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05155787
• Other study ID #: A-BR-109-031
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2024
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of NFT on sleep quality and cognitive-behavioral performance among HIV-infected patients, to use it as a reference for the construction of NFT as a clinical empirical treatment model for HIV-infected patients with sleep disturbance.

Description:

This study will aim to evaluate the effects of NFT on sleep quality and neurocognitive performance among HIV-infected persons with sleep disturbance. A double-blind clinical randomized parallel trial will be enrolled in HIV-infected persons with sleep disturbance. We will exclude subjects with OSA. Random sampling by using a computer, and then we will be divided subjects into 2 groups. 30 people will be drawn into the experimental group and control group (sham). Two groups will be treated with NFT three times a week for at least four weeks. The vague distribution of this study will be handled by SNOSE (Sequentially Numbered, Opaque, Sealed Envelopes). Double-blind subjects include subjects, family members, outcome appraisers, and technologists to ensure the integrity of randomized controlled trials and blind assignment. The outcome indicators are sleep quality and the Chinese Montreal cognitive assessment (MoCA). Treatment compliance, sample loss, and adverse event events will be monitored, and the analysis will be followed the principle of intention to treat. The pair student t or McNemar's test will use to test the effect of NFT on sleep quality and neurocognitive performances among HIV-infected persons.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: August 1, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• HIV-infected persons

Exclusion Criteria:

• Patients with central neural infections
• Pregnant women
• Drug or alcohol abuse

Related Conditions & MeSH terms

• HIV Infections
• Poor Quality Sleep

Intervention

Device:
• Neurofeedback
Neurofeedback training as a method is going to let the brain producing the alpha signal (8-13 Hz).
• Shame neurofeedback
shame neurofeedback

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Alford K, Banerjee S, Nixon E, O'Brien C, Pounds O, Butler A, Elphick C, Henshaw P, Anderson S, Vera JH. Assessment and Management of HIV-Associated Cognitive Impairment: Experience from a Multidisciplinary Memory Service for People Living with HIV. Brain — View Citation

Cicerone KD, Goldin Y, Ganci K, Rosenbaum A, Wethe JV, Langenbahn DM, Malec JF, Bergquist TF, Kingsley K, Nagele D, Trexler L, Fraas M, Bogdanova Y, Harley JP. Evidence-Based Cognitive Rehabilitation: Systematic Review of the Literature From 2009 Through — View Citation

Gamaldo CE, Gamaldo A, Creighton J, Salas RE, Selnes OA, David PM, Mbeo G, Parker BS, Brown A, McArthur JC, Smith MT. Evaluating sleep and cognition in HIV. J Acquir Immune Defic Syndr. 2013 Aug 15;63(5):609-16. doi: 10.1097/QAI.0b013e31829d63ab. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective sleep quality as assessed by Chinese version Pittsburgh Sleep Quality Index (CPSQI)	Subjective sleep quality was measured by Chinese version of the Pittsburgh Sleep Quality Index (CPSQI). A patient with a score of >=5 would be identified as poor sleep quality.	1 month
Primary	The length of minutes of total sleep time (TST) as assessed by the acti-watch	This objective outcome measures by the acti-watch (Axivity, Newcastle, UK), which contains an accelerometer for detection of movement, produces a continuous electrical signal (voltage) when a participant wore the device for up to one month.; Total sleep time (TST): TST referred to as the true sleep period, is defined as the interval (within time in bed) from sleep onset to sleep offset.	1 month
Primary	The length of minutes of sleep onset latency (SOL) as assessed by the acti-watch	This objective outcome measures by the acti-watch (Axivity, Newcastle, UK), which contains an accelerometer for detection of movement, produces a continuous electrical signal (voltage) when a participant wore the device.; Sleep onset latency (SOL): SOL refers to the number of minutes it took a subject to fall asleep. It is the number of minutes between lying down in bed and actually falling asleep.	1 month
Primary	The percentage of sleep efficiency (SE) as assessed by the acti-watch	This objective outcome measures by the acti-watch (Axivity, Newcastle, UK), which contains an accelerometer for detection of movement, produces a continuous electrical signal (voltage) when a participant wore the device for up to one month.; Sleep efficiency (SE): SE is defined as the percentage of time spent asleep during the time in bed. SE is derived as follows: SE=(TST/time in bed)×100%.	1 month
Secondary	Cognitive performance as assessed by the International HIV dementia scale (IHDS)	We will evaluate cognitive performance using International HIV dementia scale (IHDS). The maximum possible score is 12 points. A patient with a score of =10 should be evaluated further for possible HIV dementia.	1 month