NCT05155787

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Poor Quality Sleep
• HIV Infections

Interventions

Type	Name	Description
DEVICE	Neurofeedback	Neurofeedback training as a method is going to let the brain producing the alpha signal (8-13 Hz).
DEVICE	Shame neurofeedback	shame neurofeedback

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2021-12-14
• Last updated: 2025-05-22

Locations

1 site across 1 country: Taiwan