Trial Outcomes & Findings for Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk (NCT NCT03036254)
NCT ID: NCT03036254
Last Updated: 2025-08-11
Results Overview
This analysis involves 11 cognitive performance variables, each measuring a specific aspect of cognition. In general, higher scores indicate better performance (Digit Symbol measures processing speed, Semantic Fluency measures verbal fluency, Word Recall Task measures immediate verbal memory, Delayed Word Recall Test measures delayed verbal memory, and Recall Unit measures immediate and delayed story recall), except for two variables (Trail Making Test Part A measures processing speed, Trail Making Test Part B measures cognitive flexibility) that measure time (where higher values indicate worse performance). These variables are standardized using Z-scores, which allow for combining and comparing values across different scales. The standardized values (Z-scores) of all 11 measures are averaged to create the composite score. Full range of composite score is -1 to 1. Higher composite Z-score reflects better cognitive performance and more favorable outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
155 participants
Primary outcome timeframe
baseline, 12, weeks, 6 months and 12 months
Results posted on
2025-08-11
Participant Flow
155 participants were enrolled from August 10, 2017, to April 17, 2023. The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers, but the trial was concluded successfully.
Participant milestones
| Measure |
HBOT Intervention
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
78
|
|
Overall Study
COMPLETED
|
60
|
67
|
|
Overall Study
NOT COMPLETED
|
17
|
11
|
Reasons for withdrawal
| Measure |
HBOT Intervention
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
4
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
Baseline Characteristics
Hyperbaric Oxygen Therapy for Cognition in Diabetic Elderly at High Dementia Risk
Baseline characteristics by cohort
| Measure |
HBOT Intervention
n=77 Participants
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
n=78 Participants
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.7 years
STANDARD_DEVIATION 4.182 • n=5 Participants
|
70.2 years
STANDARD_DEVIATION 3.560 • n=7 Participants
|
70.94 years
STANDARD_DEVIATION 3.938 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
MENA: Middle Eastern North African
|
33 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ashkenazi
|
41 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Clinical Dementia Rating - Sum of Boxes (CDR-SB)
|
1.6 units on a scale
STANDARD_DEVIATION 1.16 • n=5 Participants
|
1.51 units on a scale
STANDARD_DEVIATION 0.80 • n=7 Participants
|
1.56 units on a scale
STANDARD_DEVIATION 0.99 • n=5 Participants
|
|
Total Mini-Mental State Examination
|
28.55 units on a scale
STANDARD_DEVIATION 1.28 • n=5 Participants
|
28.49 units on a scale
STANDARD_DEVIATION 1.36 • n=7 Participants
|
28.52 units on a scale
STANDARD_DEVIATION 1.32 • n=5 Participants
|
|
Total Beck Depression Inventory
|
5.52 units on a scale
STANDARD_DEVIATION 3.89 • n=5 Participants
|
5.34 units on a scale
STANDARD_DEVIATION 4.02 • n=7 Participants
|
5.43 units on a scale
STANDARD_DEVIATION 3.95 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 12, weeks, 6 months and 12 monthsPopulation: The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers.
This analysis involves 11 cognitive performance variables, each measuring a specific aspect of cognition. In general, higher scores indicate better performance (Digit Symbol measures processing speed, Semantic Fluency measures verbal fluency, Word Recall Task measures immediate verbal memory, Delayed Word Recall Test measures delayed verbal memory, and Recall Unit measures immediate and delayed story recall), except for two variables (Trail Making Test Part A measures processing speed, Trail Making Test Part B measures cognitive flexibility) that measure time (where higher values indicate worse performance). These variables are standardized using Z-scores, which allow for combining and comparing values across different scales. The standardized values (Z-scores) of all 11 measures are averaged to create the composite score. Full range of composite score is -1 to 1. Higher composite Z-score reflects better cognitive performance and more favorable outcomes.
Outcome measures
| Measure |
HBOT Intervention
n=77 Participants
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
n=78 Participants
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
|---|---|---|
|
Change in Global Cognition Score
Visit 1 - Baseline
|
-0.012 Composite z-score
Standard Deviation 0.65
|
0.021 Composite z-score
Standard Deviation 0.61
|
|
Change in Global Cognition Score
Visit 2 - 12 weeks
|
0.18 Composite z-score
Standard Deviation 0.67
|
0.32 Composite z-score
Standard Deviation 0.73
|
|
Change in Global Cognition Score
Visit 3 - 6 months
|
0.38 Composite z-score
Standard Deviation 0.68
|
0.48 Composite z-score
Standard Deviation 0.64
|
|
Change in Global Cognition Score
Visit 4- 12 months
|
0.34 Composite z-score
Standard Deviation 0.65
|
0.37 Composite z-score
Standard Deviation 0.77
|
PRIMARY outcome
Timeframe: baseline, 3 months, and 12 monthsPopulation: The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers
Cerebral blood flow (CBF) via arterial spin labeling magnetic resonance imaging (ASL-MRI). CBF is defined as the blood volume that flows per unit mass per unit time in brain tissue.
Outcome measures
| Measure |
HBOT Intervention
n=77 Participants
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
n=78 Participants
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
|---|---|---|
|
Cerebral Blood Flow
Baseline
|
219.39 ml blood∕100 g tissue min
Standard Deviation 60.92
|
207.86 ml blood∕100 g tissue min
Standard Deviation 83.50
|
|
Cerebral Blood Flow
3 months
|
227.68 ml blood∕100 g tissue min
Standard Deviation 68.67
|
227.64 ml blood∕100 g tissue min
Standard Deviation 49.02
|
|
Cerebral Blood Flow
12 months
|
216.91 ml blood∕100 g tissue min
Standard Deviation 50.54
|
216.91 ml blood∕100 g tissue min
Standard Deviation 50.54
|
PRIMARY outcome
Timeframe: Baseline, 12 weeks, 12 monthsPopulation: The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers
Measures how actively the brain uses glucose, highlighting areas with abnormal activity that may signal diseases like Alzheimer's. Dimmer areas suggest reduced activity seen in disorders like dementia.
Outcome measures
| Measure |
HBOT Intervention
n=77 Participants
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
n=78 Participants
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
|---|---|---|
|
Whole Brain SUVr (FDG-PET)
Visit 1 - Baseline
|
0.009 Standardized Uptake Value (SUV)
Standard Deviation 0.907
|
-0.022 Standardized Uptake Value (SUV)
Standard Deviation 1.117
|
|
Whole Brain SUVr (FDG-PET)
Visit 2 - 12 weeks
|
-0.128 Standardized Uptake Value (SUV)
Standard Deviation 1.265
|
0.379 Standardized Uptake Value (SUV)
Standard Deviation 0.973
|
|
Whole Brain SUVr (FDG-PET)
Visit 4 - 12 months
|
-0.266 Standardized Uptake Value (SUV)
Standard Deviation 0.934
|
-0.0004 Standardized Uptake Value (SUV)
Standard Deviation 0.828
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 6 months, 12 monthsPopulation: Data not collected due to decision not to administered instruments. This decision was based on participant frailty and protocol intensity-not technical issues or non-compliance-and was made to ensure feasibility and ethical conduct of the study. The NIH computerized cognitive test was never administered, and no data was collected at any time.
The sum z-scores for 3 computer-based tests (not language dependent), developed through NIH; EXAMINER assessing executive abilities: http://examiner.ucsf.edu). Early in the study, it became clear that participants-older adults with significant frailty, multiple chronic conditions (average \>4 per participant), and high medication burden (mean \>5 medications)-were finding the assessment protocol burdensome. The protocol already required repeated cognitive testing, MRI, FDG-PET imaging, and other assessments, leading many participants to report fatigue and difficulty concentrating. To prioritize participant well-being, decision made not to add the NIH computerized cognitive tests. The existing paper-and-pencil battery was well-established, sensitive to cognitive changes, and adequately covered executive function and episodic memory. The NIH computerized cognitive test was never administered, and no data was collected at any time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 12, weeks, 6 months and 12 monthsPopulation: The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers
Clinical Dementia Rating-Sum of Boxes (CDR-SB), which summarizes impairment in 6 domains (memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care) based on subject and informant interviews. Scores in each of these are combined to obtain a composite score ranging from 0 (no symptoms of dementia) through 3 (severe symptoms of dementia). Total scale from 0-18. Higher scores indicating worse cognitive status.
Outcome measures
| Measure |
HBOT Intervention
n=77 Participants
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
n=78 Participants
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
|---|---|---|
|
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Baseline
|
1.60 score on a scale
Standard Deviation 1.16
|
1.51 score on a scale
Standard Deviation 0.80
|
|
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
12 weeks
|
0.75 score on a scale
Standard Deviation 0.86
|
0.67 score on a scale
Standard Deviation 0.81
|
|
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
6 months
|
0.61 score on a scale
Standard Deviation 0.62
|
0.76 score on a scale
Standard Deviation 0.79
|
|
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
12 months
|
0.71 score on a scale
Standard Deviation 0.75
|
0.87 score on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: baseline, 12 weeks, 6 months and 12 monthsPopulation: The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers
This is a 21-item, self-report questionnaire that measures attitudes and symptoms of depression during the last week (i.e. mood, feelings of hopelessness, failure, guilt, self-esteem, etc.). Each question has a set of at least four possible responses, ranging in intensity. Total scale 0-63. Higher scores indicate more severe symptoms of depression.
Outcome measures
| Measure |
HBOT Intervention
n=77 Participants
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
n=78 Participants
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
|---|---|---|
|
Beck Depression Inventory (BDI)
Baseline
|
5.43 score on a scale
Standard Deviation 3.8
|
5.31 score on a scale
Standard Deviation 4.0
|
|
Beck Depression Inventory (BDI)
12 weeks
|
5.57 score on a scale
Standard Deviation 4.80
|
4.74 score on a scale
Standard Deviation 4.32
|
|
Beck Depression Inventory (BDI)
6 months
|
6.62 score on a scale
Standard Deviation 6.51
|
4.88 score on a scale
Standard Deviation 3.61
|
|
Beck Depression Inventory (BDI)
12 months
|
6.14 score on a scale
Standard Deviation 5.8
|
5.64 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: baseline, 12 weeks, 6 months, and 12 monthsPopulation: The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers
ADL questionnaire Participant The ADL-PI was developed, comprising 15 ADL (e.g. managing medications, managing finances) and 5 physical function (e.g. shopping and meal preparation) questions. All responses relate to the 3 months prior to the time of rating. Total range 0-30, higher scores indicate greater impairment.
Outcome measures
| Measure |
HBOT Intervention
n=77 Participants
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
n=78 Participants
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
|---|---|---|
|
Alzheimer's Disease Cooperative Study-Activities of Daily Living - Prevention Questionnaire (ADL-PI)
Baseline
|
24.34 score on a scale
Standard Deviation 4.041
|
24.60 score on a scale
Standard Deviation 3.81
|
|
Alzheimer's Disease Cooperative Study-Activities of Daily Living - Prevention Questionnaire (ADL-PI)
12 weeks
|
25.43 score on a scale
Standard Deviation 4.53
|
25.58 score on a scale
Standard Deviation 3.99
|
|
Alzheimer's Disease Cooperative Study-Activities of Daily Living - Prevention Questionnaire (ADL-PI)
6 months
|
25.71 score on a scale
Standard Deviation 3.76
|
25.84 score on a scale
Standard Deviation 4.00
|
|
Alzheimer's Disease Cooperative Study-Activities of Daily Living - Prevention Questionnaire (ADL-PI)
12 months
|
26.29 score on a scale
Standard Deviation 3.20
|
25.47 score on a scale
Standard Deviation 4.02
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 6 months, and 12 monthsPopulation: The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers
ADL Informant This tool is based on caregiver's report to assess participants' abilities to perform basic and instrumental activities of daily living (ADLs) like bathing, walking and self-grooming. All responses should relate to the 4 weeks prior to the time of rating. Full Scale range from 0-53, higher score indicates more impairment for the participant.
Outcome measures
| Measure |
HBOT Intervention
n=77 Participants
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
n=78 Participants
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
|---|---|---|
|
Alzheimer's Disease Cooperative Study-Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL MCI)
Baseline
|
45.24 score on a scale
Standard Deviation 6.12
|
44.71 score on a scale
Standard Deviation 5.9
|
|
Alzheimer's Disease Cooperative Study-Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL MCI)
12 weeks
|
47.5 score on a scale
Standard Deviation 5.67
|
48.41 score on a scale
Standard Deviation 4.49
|
|
Alzheimer's Disease Cooperative Study-Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL MCI)
6 months
|
47.69 score on a scale
Standard Deviation 5.66
|
47.29 score on a scale
Standard Deviation 5.33
|
|
Alzheimer's Disease Cooperative Study-Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL MCI)
12 months
|
48.98 score on a scale
Standard Deviation 3.67
|
48.32 score on a scale
Standard Deviation 6.07
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 6 months, and 12 monthsPopulation: The Covid-19 pandemic caused a 14-month pause, affecting follow-up numbers
Total range 0-30, higher scores indicate better cognitive function.
Outcome measures
| Measure |
HBOT Intervention
n=77 Participants
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
n=78 Participants
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
|---|---|---|
|
Total Mini-Mental State Examination (MMSE)
Baseline
|
28.56 score on a scale
Standard Deviation 1.30
|
28.49 score on a scale
Standard Deviation 1.37
|
|
Total Mini-Mental State Examination (MMSE)
12 weeks
|
28.26 score on a scale
Standard Deviation 1.63
|
28.38 score on a scale
Standard Deviation 1.77
|
|
Total Mini-Mental State Examination (MMSE)
6 months
|
28.04 score on a scale
Standard Deviation 1.89
|
28.53 score on a scale
Standard Deviation 1.53
|
|
Total Mini-Mental State Examination (MMSE)
12 months
|
28.32 score on a scale
Standard Deviation 1.68
|
28.18 score on a scale
Standard Deviation 2.21
|
Adverse Events
HBOT Intervention
Serious events: 18 serious events
Other events: 55 other events
Deaths: 3 deaths
Sham Intervention
Serious events: 6 serious events
Other events: 51 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
HBOT Intervention
n=77 participants at risk
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
n=78 participants at risk
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute cough
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Barotrauma
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Surgical and medical procedures
Bypass surgery
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Cardiac disorders
Cardiac Arrythmia
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Surgical and medical procedures
Cardiac catheterization
|
3.9%
3/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
General disorders
Chest pain
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
General disorders
Deceased
|
3.9%
3/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
1/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.3%
1/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Nervous system disorders
Intracranial pressure increase
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Surgical and medical procedures
Knee arthroplasty
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer stage IV
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Injury, poisoning and procedural complications
Metatarsal fracture
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
1/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Surgical and medical procedures
Parathyroidectomy
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Pneumonia
|
1.3%
1/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Eye disorders
Retinal detachment
|
2.6%
2/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Surgical and medical procedures
Shoulder replacement
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Nervous system disorders
Stroke
|
2.6%
2/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Nervous system disorders
Syncope
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Urinary infection
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
General disorders
Weakness
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
Other adverse events
| Measure |
HBOT Intervention
n=77 participants at risk
The multiplace HBOT unit at Asaf Harofeh. The inside looks like an airplane, with comfortable chairs for 11 subjects and the nurse who stays throughout the session. The HBOT protocol is 90 minutes, 5 times/week, 60 sessions, 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes.
|
Sham Intervention
n=78 participants at risk
The sham condition replicates all experiential aspects of the HBOT therapy except for the degree of pressure and oxygen levels. The sham condition exposes subjects to 1.1 ATA, which provides a pressure sensation in addition to the noise of air circulation. Pressure then decreases very slowly during the next half hour; in the last 5 minutes of the session, air is circulated again with its related noise.
|
|---|---|---|
|
Infections and infestations
Abscess in the throat
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuromas
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Nervous system disorders
Arachnoid granulation
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Cardiac disorders
Atrial fibrilation
|
0.00%
0/77 • 12 months
|
2.6%
2/78 • 12 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/77 • 12 months
|
2.6%
2/78 • 12 months
|
|
Eye disorders
Avastin eye injection
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
5/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Bacteremia
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Barotrauma
|
26.0%
20/77 • 12 months
|
5.1%
4/78 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basalioma
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Psychiatric disorders
BDI=22
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Eye disorders
Blurry vision
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Bone spur
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Bronchitis
|
2.6%
2/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Bruised ear
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Surgical and medical procedures
Cardiac catheterization
|
3.9%
3/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Eye disorders
Cataract
|
7.8%
6/77 • 12 months
|
2.6%
2/78 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cavernoma
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
General disorders
Chest pain
|
2.6%
2/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Psychiatric disorders
Claustrophobia
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Cold
|
2.6%
2/77 • 12 months
|
2.6%
2/78 • 12 months
|
|
Gastrointestinal disorders
Colon inflammation
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Surgical and medical procedures
Colonoscopy
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Covid 19
|
13.0%
10/77 • 12 months
|
11.5%
9/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Diabetic foot ulcer
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Eye disorders
Diplopia
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Psychiatric disorders
Exacerbation of post traumatic symptoms (BDI=24)
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Eye disorders
Eye pain
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Nervous system disorders
Facial paralysis
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
6.5%
5/77 • 12 months
|
5.1%
4/78 • 12 months
|
|
Nervous system disorders
Fasciculation
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Injury, poisoning and procedural complications
Fracture of the coccyx
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Eye disorders
Glaucoma
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Gum infection
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Injury, poisoning and procedural complications
Hand tendon injury
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Head injury
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Injury, poisoning and procedural complications
Hip injury
|
1.3%
1/77 • 12 months
|
2.6%
2/78 • 12 months
|
|
Surgical and medical procedures
Hip replacement
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Vascular disorders
Hypertension
|
3.9%
3/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
General disorders
Hypothermia
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/77 • 12 months
|
5.1%
4/78 • 12 months
|
|
Skin and subcutaneous tissue disorders
Itchy skin
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Renal and urinary disorders
Kidney stones
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Knee effusion
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Knee fracture
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar disc herniation
|
1.3%
1/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Surgical and medical procedures
Lumbar puncture
|
1.3%
1/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Injury, poisoning and procedural complications
Metatarsal fracture
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Investigations
MRI brain abnormal
|
1.3%
1/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Surgical and medical procedures
Myringotomy
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Nervous system disorders
Neuropathy
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pains in legs
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Injury, poisoning and procedural complications
Post traumatic pain
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Surgical and medical procedures
Prostate resection
|
1.3%
1/77 • 12 months
|
3.8%
3/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Surgical and medical procedures
Shoulder replacement
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/77 • 12 months
|
2.6%
2/78 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin cyst
|
2.6%
2/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Gastrointestinal disorders
Stomach ache
|
0.00%
0/77 • 12 months
|
2.6%
2/78 • 12 months
|
|
Nervous system disorders
Stroke
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Nervous system disorders
Syncope
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Eye disorders
Vision decreased
|
2.6%
2/77 • 12 months
|
1.3%
1/78 • 12 months
|
|
Eye disorders
Vitreous detachment
|
1.3%
1/77 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/77 • 12 months
|
3.8%
3/78 • 12 months
|
|
General disorders
Weakness
|
0.00%
0/77 • 12 months
|
2.6%
2/78 • 12 months
|
Additional Information
Dr. Mary Sano
Icahn School of Medicine at Mount Sinai
Phone: (212) 659-8838
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the sponsor (or its agent) and any non-employee PI(s) that restricts the PI's rights to discuss or publish trial results after the Primary Completion Date.
- Publication restrictions are in place
Restriction type: OTHER