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

Primary Purpose

Poor Quality Sleep, HIV Infections

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Neurofeedback
Shame neurofeedback
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Poor Quality Sleep focused on measuring neurocognitive performance, neurofeedback training

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV-infected persons

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Group with neurofeedback training

Group with shame neurofeedback training

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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%.

Secondary Outcome Measures

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.

Full Information

First Posted
April 4, 2021
Last Updated
March 27, 2023
Sponsor
National Cheng-Kung University Hospital
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05155787
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poor Quality Sleep, HIV Infections
Keywords
neurocognitive performance, neurofeedback training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group with neurofeedback training
Arm Type
Experimental
Arm 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.
Arm Title
Group with shame neurofeedback training
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Neurofeedback
Intervention Description
Neurofeedback training as a method is going to let the brain producing the alpha signal (8-13 Hz).
Intervention Type
Device
Intervention Name(s)
Shame neurofeedback
Intervention Description
shame neurofeedback
Primary Outcome Measure Information:
Title
Subjective sleep quality as assessed by Chinese version Pittsburgh Sleep Quality Index (CPSQI)
Description
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.
Time Frame
1 month
Title
The length of minutes of total sleep time (TST) as assessed by the acti-watch
Description
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.
Time Frame
1 month
Title
The length of minutes of sleep onset latency (SOL) as assessed by the acti-watch
Description
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.
Time Frame
1 month
Title
The percentage of sleep efficiency (SE) as assessed by the acti-watch
Description
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%.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Cognitive performance as assessed by the International HIV dementia scale (IHDS)
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-infected persons Exclusion Criteria: Patients with central neural infections Pregnant women Drug or alcohol abuse
Facility Information:
Facility Name
National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
City
Tainan
ZIP/Postal Code
704
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30744034
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.
Results Reference
result
PubMed Identifier
30926291
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.
Results Reference
result
PubMed Identifier
23722610
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.
Results Reference
result

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

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