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

NCT ID: NCT05155787

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-07-31

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.

Conditions

Poor Quality Sleep; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group with neurofeedback training

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.

Group Type: EXPERIMENTAL

Neurofeedback

Intervention Type: DEVICE

Neurofeedback training as a method is going to let the brain producing the alpha signal (8-13 Hz).

Group with shame neurofeedback training

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 Type: SHAM_COMPARATOR

Shame neurofeedback

Intervention Type: DEVICE

shame neurofeedback

Interventions

Neurofeedback

Neurofeedback training as a method is going to let the brain producing the alpha signal (8-13 Hz).

Intervention Type: DEVICE

Shame neurofeedback

shame neurofeedback

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• HIV-infected persons

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen, Yen-Chin

Vice Head Nurse and Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan

Tainan City, Taiwan, Taiwan

Countries

Taiwan

References

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 Sci. 2019 Feb 8;9(2):37. doi: 10.3390/brainsci9020037.

Reference Type: BACKGROUND

PMID: 30744034 (View on PubMed)

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 2014. Arch Phys Med Rehabil. 2019 Aug;100(8):1515-1533. doi: 10.1016/j.apmr.2019.02.011. Epub 2019 Mar 26.

Reference Type: BACKGROUND

PMID: 30926291 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23722610 (View on PubMed)

Other Identifiers

A-BR-109-031

Identifier Type: -

Identifier Source: org_study_id