Trial Outcomes & Findings for AcuSleep in Mild Traumatic Brain Injury (TBI) (NCT NCT01162317)

Last Updated: 2018-01-19

Results Overview

change of global PSQI score as compared to baseline The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The PSQI global score has a possible range of 0-21 points. Any score above 5 is considered insomnia. The higher the score the worse the condition.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Baseline and post-intervention

Results posted on

2018-01-19

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: Sham Acupuncture sham acupuncture Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration.	Arm 2: Acupuncture acupuncture Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes.
Overall Study STARTED	30	30
Overall Study COMPLETED	27	28
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AcuSleep in Mild Traumatic Brain Injury (TBI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Sham Acupuncture n=30 Participants sham acupuncture Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration.	Arm 2: Acupuncture n=30 Participants acupuncture Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=93 Participants	30 Participants n=4 Participants	60 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	40 years STANDARD_DEVIATION 10.3 • n=93 Participants	39.6 years STANDARD_DEVIATION 9.7 • n=4 Participants	39.8 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	24 Participants n=4 Participants	46 Participants n=27 Participants
Region of Enrollment United States	30 Participants n=93 Participants	30 Participants n=4 Participants	60 Participants n=27 Participants
Pittsburgh Sleep Quality Index (PSQI)	14.33 units on a scale STANDARD_DEVIATION 3.10 • n=93 Participants	14.17 units on a scale STANDARD_DEVIATION 3.41 • n=4 Participants	14.26 units on a scale STANDARD_DEVIATION 3.20 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline and post-intervention

Outcome measures

Outcome measures
Measure	Arm 1: Sham Acupuncture n=30 Participants sham acupuncture Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration.	Arm 2: Acupuncture n=30 Participants acupuncture Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes.
PSQI Change	-2.38 change of points from baseline Standard Deviation 3.41	-4.43 change of points from baseline Standard Deviation 3.86

SECONDARY outcome

Timeframe: pre-intervention, post-intervention (1wk of recording each)

Population: All obtained actigraphy data were analyzed. This form doesn't allow specific indication of sample sizes. Therefore, here overall numbers of participants analyzed were the same as the maximal potential.

Wrist actigraphy is a non-invasive method of continuously monitoring gross body activities when a watch-like actimetry sensor is worn at the non-dominant wrist. An algorithm has been developed to assess sleep/wake behavior. Specifically in this study, we used Respironics® actiwatches for data collection. Subjects were asked to wear the actiwatches for a consecutive week at baseline and then at post-intervention, and the actiwatches were taken off only during showers. Wrist actigraphy was examined in association with sleep diary the subjects were to keep for the weeks of monitoring. Threshold-based method algorithm for data interpretation was provided by Respironics® Actiware Software. Medium level threshold was set to detect Wake and Sleep; sleep interval detection algorithm was set for 3 minutes of immobile minutes for Sleep Onset and 5 minutes of immobile minutes for Sleep End. Sleep efficiency is sleep duration divided by total bed time (both in minutes), times 100%.

Outcome measures

Outcome measures
Measure	Arm 1: Sham Acupuncture n=30 Participants sham acupuncture Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration.	Arm 2: Acupuncture n=30 Participants acupuncture Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes.
Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency Pre-intervention	73.57 percentage Standard Deviation 13.21	72.57 percentage Standard Deviation 16.41
Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency Post-intervention	67.94 percentage Standard Deviation 13.28	76.68 percentage Standard Deviation 12.18

Adverse Events

Arm 1: Sham Acupuncture

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 2: Acupuncture

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 1: Sham Acupuncture n=30 participants at risk sham acupuncture Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration.	Arm 2: Acupuncture n=30 participants at risk acupuncture Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes.
Skin and subcutaneous tissue disorders Needle site pain	10.0% 3/30	26.7% 8/30

Additional Information

Wei Huang (PI)

Atlanta VAMC

Phone: 404-321-6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place