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

National Cheng-Kung University

Status: Completed

Conditions: Poor Quality Sleep; HIV Infections

Treatments: Device: Shame neurofeedback; Device: Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05155787

A-BR-109-031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-infected persons

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 2 patient groups

Group with neurofeedback training

Experimental group

Description:

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.

Treatment:

Device: Neurofeedback

Group with shame neurofeedback training

Sham Comparator group

Description:

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.

Treatment:

Device: Shame neurofeedback