Clinical trial NCT05155787: Neurofeedback Training (NFT) on Sleep Quality and Cognitive Function Performance Among HIV-infected Persons
Official title: Construction and Evaluation of Neurofeedback Training (NFT) on Sleep Quality and Cognitive Function Performance Among HIV-infected Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Quality Sleep
HIV Infections
Keywords: neurocognitive performance, neurofeedback training
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2021-12-14
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* HIV-infected persons

Exclusion Criteria:

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

Primary outcomes:
measure: Subjective sleep quality as assessed by Chinese version Pittsburgh Sleep Quality Index (CPSQI)
timeFrame: 1 month
measure: The length of minutes of total sleep time (TST) as assessed by the acti-watch
timeFrame: 1 month
measure: The length of minutes of sleep onset latency (SOL) as assessed by the acti-watch
timeFrame: 1 month
measure: The percentage of sleep efficiency (SE) as assessed by the acti-watch
timeFrame: 1 month
Secondary outcomes:
measure: Cognitive performance as assessed by the International HIV dementia scale (IHDS)
timeFrame: 1 month
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.