HIV Infections Clinical Trial
Official title:
Construction and Evaluation of Neurofeedback Training (NFT) on Sleep Quality and Cognitive Function Performance Among HIV-infected Persons
Verified date | March 2024 |
Source | National Cheng-Kung University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | August 1, 2024 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 100 Years |
Eligibility | Inclusion Criteria: - HIV-infected persons Exclusion Criteria: - Patients with central neural infections - Pregnant women - Drug or alcohol abuse |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan | Tainan |
Lead Sponsor | Collaborator |
---|---|
National Cheng-Kung University Hospital | Ministry of Science and Technology, Taiwan |
Taiwan,
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 — View 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 — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Cognitive performance as assessed by the International HIV dementia scale (IHDS) | We will evaluate cognitive performance using International HIV dementia scale (IHDS). The maximum possible score is 12 points. A patient with a score of =10 should be evaluated further for possible HIV dementia. | 1 month |
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