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

Not Applicable

• Conditions: HIV Infections; Poor Quality Sleep
• Interventions: Device: Shame neurofeedback; Device: Neurofeedback

• Registration Number: NCT05155787
• Lead Sponsor: National Cheng-Kung University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-04-04
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2021-12-14
• Primary Completion: 2023-07-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-24
• Last Update Posted: 2024-03-26
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• HIV-infected persons

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group with shame neurofeedback training	Shame neurofeedback	In the shame group, the system is not feedback to the actual wave. Each person will arrange training three times a week for four weeks.
Group with neurofeedback training	Neurofeedback	The neurofeedback training system records the brain waves from the subject and converts the original brain wave signal into frequency energy through spectrum analysis. The system will help the subject to find self relax method for producing more alpha waves. Each person will arrange training three times a week for four weeks.

Primary Outcome Measures

Name	Time	Method
Subjective sleep quality as assessed by Chinese version Pittsburgh Sleep Quality Index (CPSQI)	1 month	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.
The length of minutes of total sleep time (TST) as assessed by the acti-watch	1 month	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.
The percentage of sleep efficiency (SE) as assessed by the acti-watch	1 month	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%.
The length of minutes of sleep onset latency (SOL) as assessed by the acti-watch	1 month	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.

Secondary Outcome Measures

Name	Time	Method
Cognitive performance as assessed by the International HIV dementia scale (IHDS)	1 month	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.

Trial Locations

Locations (1)

National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; 🇨🇳 Tainan, Taiwan