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

NCT05155787 | Completed DMC

• 1 other identifier: A-BR-109-031
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Poor Quality Sleep; HIV Infections

Keywords

neurocognitive performance, neurofeedback training

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Cognitive performance as assessed by the International HIV dementia scale (IHDS)

  1 month

Study Arms (2)

Group with neurofeedback training

EXPERIMENTAL

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.

Device: Neurofeedback

Group with shame neurofeedback training

SHAM COMPARATOR

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.

Device: Shame neurofeedback

Interventions

Neurofeedback DEVICE

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

Group with neurofeedback training

Shame neurofeedback DEVICE

shame neurofeedback

Group with shame neurofeedback training

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected persons

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

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

Tainan, Taiwan, 704, Taiwan

Location

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

  PMID: 30744034 BACKGROUND

• 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.

  PMID: 30926291 BACKGROUND

• 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.

  PMID: 23722610 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Head Nurse and Clinical Assistant Professor

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: December 14, 2021
• Study Start: March 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 22, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)