Acu-TENS and Acupressure on the Sleep Quality

A Clinical Investigation of the Effects of Acu-TENS and Acupressure on the Sleep Quality of Older Adults With Insomnia: A Pilot Randomized, Placebo-controlled Clinical Trial

The study aims to investigate the effects of two non-invasive acupuncture methodologies applied to three selected acupoints on the sleep quality of older adults with insomnia.

The investigators invite participants to participate in the study (12 treatments [3 times/week, 4 weeks in total], 3 tests), which will take about 2 months in total. Participants will be randomly allocated to three independent groups, i.e., a placebo group or one of two treatment groups, viz., a transcutaneous electrical nerve-stimulation group (Acu-TENS) or an acupressure group. The Acu-TENS group will receive Acu-TENS + a sleep hygiene program (SHP). The acupressure group will receive acupressure + SHP. The placebo group will receive a placebo stimulation+ SHP. Each group will have a 4-week treatment comprising thrice-weekly 30-min sessions of treatment.

For Acu-TENS, electrodes will be attached to participants' sleep-related acupoints for 30 minutes. For acupressure, the investigators will guide participants to apply pressure to each sleep-related acupoint for 5 minutes, for a total of 30 minutes. The process of Sham Acu-TENS stimulation will be the same as Acu-TENS, but the instrument model is different. SHP is a training course in which the investigators will guide participants on how to improve participants' sleep quality by adjusting participants' lifestyle. The sleep quality (survey and actigraphy), insomnia index, heart rate variability, level of fatigue (survey), mood (survey) and quality of life (survey) will be measured at the baseline assessment (before the treatment), post-treatment assessment (after the four weeks treatment) and follow-up assessment (two weeks after the treatment ended). The investigators will give participants a watch to wear for one week during sleep measurement and then please return it. The watch will record participants' sleep data. For the heart rate variability measurement, participants will need to wear a heart rate monitor in the lab for a short period. After the trials, Participants will have the opportunity to know participants' level of sleep quality and some mental conditions (i.e., mood, fatigue, quality of life). Participants may experience mild skin irritation during treatment. If participants feel uncomfortable, please inform the researcher to reduce the irritation to a relatively comfortable level.

Study Overview

• Status: Completed
• Conditions: Insomnia; Sleep Quality; Acupressure; acuTENS
• Intervention / Treatment: Device: Acu-TENS; Other: sleep hygiene program(SHP); Other: acupressure+SHP; Other: placebo stimulation+SHP

Detailed Description

Insomnia is the most common sleep disorder that affects older adults. This proposed study aims to investigate the effects of two acupuncture methodology applied to three selected acupoints on the sleep quality of older adults with insomnia. The study will be a single-blind randomized controlled trial with a pre-post design and involve three parallel groups of older adult participants (aged > 55 years) diagnosed with insomnia. The participants will be randomly allocated to three independent groups, i.e., a placebo group or one of two treatment groups, viz., a transcutaneous electrical nerve-stimulation group (Acu-TENS) or an acupressure group. The Acu-TENS group will receive a 4-week treatment comprising thrice-weekly 30-min sessions of Acu-TENS + a sleep hygiene program (SHP). The acupressure group will receive acupressure + SHP. The selected acupoints will be bilateral Sanyinjiao (SP6) on the legs and Shenmen (HT7) and Neiguan (PC6) on the wrists. The placebo group will receive a placebo stimulation+ SHP. The primary outcomes of the study will be sleep quality, insomnia index as well as actigraphy. The secondary outcomes will be heart rate variability, level of fatigue, mood, and quality of life. All the outcomes will be measured at the baseline assessment (before the treatment), post-treatment assessment (after the four weeks treatment) and follow-up assessment (two weeks after the treatment ended). It is hypothesized that the Acu-TENS + SHP treatment will better alleviate insomnia in participants than acupressure + SHP or placebo stimulation + SHP.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• aged 55 years or older; and
• self-reported poor sleep quality (PSQI, scores ≥ 6) in the past 4 weeks

Exclusion Criteria:

• an amputation or recent fracture of upper or lower limbs;
• a severe disease that precludes the receipt of Acu-TENS or acupressure (e.g., renal impairment; epilepsy; cardiac pace-mark or another electrical or metal implant in participants' body);
• taking medication that may affect sleep;
• skin lesions, infection, or inflammation near selected acupoints; or
• a psychiatrically diagnosed mental disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acu-TENS+SHP; Participants in the Acu-TENS group will receive Acu-TENS coupled with a sleep hygiene program (SHP). 4 weeks and comprise thrice-weekly 30-min sessions.	Device: Acu-TENS; A TENS stimulator will be used (NeuroTrac TENS; Verity Medical Ltd., Wexford, Ireland). Electrodes will be placed over selected acupoints (i.e., bilateral SP6, PC6 and HT7) and connected to the TENS stimulator. These acupoints are selected according to the traditional Chinese medicine and results of previous studies. The stimulation will be lasted 30-min for each session. The frequency of the stimulation parameter's waveform will be set to 100 Hz and the square pulses will be set to 0.2-ms. The intensity of the stimulation will be below motor threshold and lower than the intolerable level, and hence, participants will feel a pleasant and mild aching sensation.; Other: sleep hygiene program(SHP); SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. The sleep guide contains information on how much sleep is needed by every individual daily, factors that could affect sleep, and risk factors for sleep disorders. It also contains information on the types of sleep disorders, delayed sleep syndrome, insomnia-producing behavior that could affect sleep quality, and suggestions for inducing sleep. The participants will be instructed to read the guide after the baseline assessment (T0). Those instructions will be reinforced by the research practitioner after each treatment session, in order to maintain the healthy sleeping habits.
Experimental: acupressure+SHP; The acupressure group will receive acupressure and SHP. 4 weeks and comprise thrice-weekly 30-min sessions.	Other: sleep hygiene program(SHP); SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. The sleep guide contains information on how much sleep is needed by every individual daily, factors that could affect sleep, and risk factors for sleep disorders. It also contains information on the types of sleep disorders, delayed sleep syndrome, insomnia-producing behavior that could affect sleep quality, and suggestions for inducing sleep. The participants will be instructed to read the guide after the baseline assessment (T0). Those instructions will be reinforced by the research practitioner after each treatment session, in order to maintain the healthy sleeping habits.; Other: acupressure+SHP; Participants in the acupressure group will receive acupressure coupled with SHP. The acupressure protocol was developed based on a protocol recommended by a review and will comprise the following: (1) applying consistent finger-tip pressure of 3-5 kg, with rotational movements; (2) counterclockwise and then clockwise circular motions for 2.5-min each; (3) confirming the precision of the acupressure based on participants feeling pain, numbness, distension, or warmth at the point of application; and (4) an acupoint sequence from the leg to the head, first on the left side of the body and then on the right side of the body; and (5) a 5-min treatment on each acupoint (i.e., bilateral SP6, PC6, and HT7) in each 30-min session. The SHP is the same with Acu-TENS+SHP group.
Placebo Comparator: placebo stimulation+SHP; The placebo group will receive a placebo stimulation and SHP. 4 weeks and comprise thrice-weekly 30-min sessions.	Other: sleep hygiene program(SHP); SHP is a set of instructions designed to help with sleep and promote healthy sleeping habits. The sleep guide contains information on how much sleep is needed by every individual daily, factors that could affect sleep, and risk factors for sleep disorders. It also contains information on the types of sleep disorders, delayed sleep syndrome, insomnia-producing behavior that could affect sleep quality, and suggestions for inducing sleep. The participants will be instructed to read the guide after the baseline assessment (T0). Those instructions will be reinforced by the research practitioner after each treatment session, in order to maintain the healthy sleeping habits.; Other: placebo stimulation+SHP; Participants in the placebo stimulation + SHP group will receive 30-minute placebo stimulation from identical-looking TENS devices with the electrical circuit disconnected inside.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh sleep quality index (PSQI)	The Pittsburgh sleep quality index is a 19-item self-report survey designed to assess subjective sleep quality across 4 weeks. It has been used in both research and clinical settings to evaluate sleep quality and screen for sleep disturbances. The scores ranges from 0 to 21. A higher score means a lower sleep quality, with a score ≥ 6 as the cut-off value for poor sleep quality. The Chinese version will be used in the proposed study.	T0, baseline
Pittsburgh sleep quality index (PSQI)	The Pittsburgh sleep quality index is a 19-item self-report survey designed to assess subjective sleep quality across 4 weeks. It has been used in both research and clinical settings to evaluate sleep quality and screen for sleep disturbances. The scores ranges from 0 to 21. A higher score means a lower sleep quality, with a score ≥ 6 as the cut-off value for poor sleep quality. The Chinese version will be used in the proposed study.	T1, post (4th week)
Pittsburgh sleep quality index (PSQI)	The Pittsburgh sleep quality index is a 19-item self-report survey designed to assess subjective sleep quality across 4 weeks. It has been used in both research and clinical settings to evaluate sleep quality and screen for sleep disturbances. The scores ranges from 0 to 21. A higher score means a lower sleep quality, with a score ≥ 6 as the cut-off value for poor sleep quality. The Chinese version will be used in the proposed study.	T2, follow-up(6th week)
Insomnia severity index (ISI)	The ISI is a self-report survey designed to assess the subjective perception of the severity of insomnia. It comprises seven items measuring the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early-morning awakenings), satisfaction with the current sleep pattern, the adverse effects of insomnia on daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 to 4, and the total score ranges from 0 to 28. A higher score represents more severe insomnia. The Chinese version will be used in the proposed study.	T0, baseline
Insomnia severity index (ISI)	The ISI is a self-report survey designed to assess the subjective perception of the severity of insomnia. It comprises seven items measuring the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early-morning awakenings), satisfaction with the current sleep pattern, the adverse effects of insomnia on daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 to 4, and the total score ranges from 0 to 28. A higher score represents more severe insomnia. The Chinese version will be used in the proposed study.	T1, post (4th week)
Insomnia severity index (ISI)	The ISI is a self-report survey designed to assess the subjective perception of the severity of insomnia. It comprises seven items measuring the severity of sleep-onset and sleep maintenance difficulties (both nocturnal and early-morning awakenings), satisfaction with the current sleep pattern, the adverse effects of insomnia on daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a scale from 0 to 4, and the total score ranges from 0 to 28. A higher score represents more severe insomnia. The Chinese version will be used in the proposed study.	T2, follow-up(6th week)
Total sleep time	Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' total sleep time (total time asleep from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.	T0, baseline
Total sleep time	Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' total sleep time (total time asleep from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.	T1, post (4th week)
Total sleep time	Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' total sleep time (total time asleep from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.	T2, follow-up(6th week)
Sleep efficiency	Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' sleep efficiency (percentage of total time in bed trying to sleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.	T0, baseline
Sleep efficiency	Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' sleep efficiency (percentage of total time in bed trying to sleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.	T1, post (4th week)
Sleep efficiency	Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants' sleep efficiency (percentage of total time in bed trying to sleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.	T2, follow-up(6th week)
Sleep onset latency	Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'sleep onset latency (time to fall asleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.	T1, post (4th week)
Sleep onset latency	Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'sleep onset latency (time to fall asleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.	T0, baseline
Sleep onset latency	Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'sleep onset latency (time to fall asleep). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.	T2, follow-up(6th week)
Time awake after sleep onset	Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'time awake after sleep onset (total time awake from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.	T1, post (4th week)
Time awake after sleep onset	Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'time awake after sleep onset (total time awake from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.	T0, baseline
Time awake after sleep onset	Actigraphy (Ambulatory Monitoring, Inc., Ardsley, NY, or equivalent device) will be used to measure participants'time awake after sleep onset (total time awake from sleep onset to waking). Actigraphy is a non-invasive technique that involves the use of a wearable device to objectively measure sleep in terms of ambulation. Thus, actigraphic sleep metrics are based on the principle that sleep is characterized by the relative absence of movement. Participants will be instructed to wear an actigraphy device on one of their legs and press the event-marker to record bedtimes and rise time for three consecutive days at each assessment point (i.e., T0, T1, T2). The validity of this assessment was confirmed in previous research.	T2, follow-up(6th week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability (HRV)	Heart rate and heart rate variability will be measured by electrocardiography (ECG; SphygmoCor, AtCor Medical, Sydney, Australia, or equivalent device), using a device that acquires, stores, and processes electrocardiogram signals. Participants will be measured in the morning between 8:00 to 11:00 am. The sympathetic nervous activity, and the high frequency will be used to indicate parasympathetic nervous activity.	T0, baseline
Heart Rate Variability (HRV)	Heart rate and heart rate variability will be measured by electrocardiography (ECG; SphygmoCor, AtCor Medical, Sydney, Australia, or equivalent device), using a device that acquires, stores, and processes electrocardiogram signals. Participants will be measured in the morning between 8:00 to 11:00 am. The sympathetic nervous activity, and the high frequency will be used to indicate parasympathetic nervous activity.	T1, post (4th week)
Heart Rate Variability (HRV)	Heart rate and heart rate variability will be measured by electrocardiography (ECG; SphygmoCor, AtCor Medical, Sydney, Australia, or equivalent device), using a device that acquires, stores, and processes electrocardiogram signals. Participants will be measured in the morning between 8:00 to 11:00 am. The sympathetic nervous activity, and the high frequency will be used to indicate parasympathetic nervous activity.	T2, follow-up(6th week)
Depression Anxiety Stress Scale	Participants' mood will be measured using the Depression Anxiety Stress Scale, a 21-item survey that assesses depression, anxiety, and stress. Each index (i.e., depression, anxiety, and stress) comprises seven items. The scores ranges from 0 to 42. Higher score indicates more sever symptom. The reliability of this scale was confirmed in previous research.	T0, baseline
Depression Anxiety Stress Scale	Participants' mood will be measured using the Depression Anxiety Stress Scale, a 21-item survey that assesses depression, anxiety, and stress. Each index (i.e., depression, anxiety, and stress) comprises seven items. The scores ranges from 0 to 42. Higher score indicates more sever symptom. The reliability of this scale was confirmed in previous research.	T1, post (4th week)
Depression Anxiety Stress Scale	Participants' mood will be measured using the Depression Anxiety Stress Scale, a 21-item survey that assesses depression, anxiety, and stress. Each index (i.e., depression, anxiety, and stress) comprises seven items. The scores ranges from 0 to 42. Higher score indicates more sever symptom. The reliability of this scale was confirmed in previous research.	T2, follow-up(6th week)
The Fatigue Assessment Scale	The Fatigue Assessment Scale will be used to measure participants' general fatigue. It is a 10-item survey, of which 5 items assess physical fatigue and the remaining 5 items assess mental fatigue. The total score ranges from 10 to 50, and a total score ≥ 22 indicates fatigue. The translated Chinese version will be used in the proposed study.	T0, baseline
The Fatigue Assessment Scale	The Fatigue Assessment Scale will be used to measure participants' general fatigue. It is a 10-item survey, of which 5 items assess physical fatigue and the remaining 5 items assess mental fatigue. The total score ranges from 10 to 50, and a total score ≥ 22 indicates fatigue. The translated Chinese version will be used in the proposed study.	T1, post (4th week)
The Fatigue Assessment Scale	The Fatigue Assessment Scale will be used to measure participants' general fatigue. It is a 10-item survey, of which 5 items assess physical fatigue and the remaining 5 items assess mental fatigue. The total score ranges from 10 to 50, and a total score ≥ 22 indicates fatigue. The translated Chinese version will be used in the proposed study.	T2, follow-up(6th week)
Health-related Quality of Life (QoL)	The 12-item Short-Form Survey will be used to measure participants' QoL. This instrument contains eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The total score ranges from 0 to 100, with a higher score indicating better QoL. The translated Cantonese version will be used in this proposed study .	T0, baseline
Health-related Quality of Life (QoL)	The 12-item Short-Form Survey will be used to measure participants' QoL. This instrument contains eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The total score ranges from 0 to 100, with a higher score indicating better QoL. The translated Cantonese version will be used in this proposed study .	T1, post (4th week)
Health-related Quality of Life (QoL)	The 12-item Short-Form Survey will be used to measure participants' QoL. This instrument contains eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The total score ranges from 0 to 100, with a higher score indicating better QoL. The translated Cantonese version will be used in this proposed study .	T2, follow-up(6th week)

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2022ShamayAcu-tens

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No