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Early Treatment of Amyotrophic Lateral Sclerosis (ALS) With Nutrition and Non-Invasive Positive Pressure Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00116558
Recruitment Status : Completed
First Posted : June 30, 2005
Results First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Edward Kasaraskis, University of Kentucky

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Amyotrophic Lateral Sclerosis
Interventions Device: Early NIPPV
Device: Standard NIPPV
Enrollment 153
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard of Care NIPPV and Nutritional Monitoring Standard of Care NIPPV Early NIPPV
Hide Arm/Group Description Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status. Participants with 50-74% predicted forced vital capacity (FVC). Participants with >80% predicted forced vital capacity (FVC).
Period Title: Overall Study
Started 80 26 47
Completed 49 11 14
Not Completed 31 15 33
Reason Not Completed
Death             11             5             3
Withdrawal by Subject             17             3             12
disease progression             3             7             18
Arm/Group Title Standard of Care NIPPV and Nutritional Monitoring Standard of Care NIPPV Early NIPPV Intervention Total
Hide Arm/Group Description Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status. Participants with 50-74% predicted forced vital capacity (FVC). Participants with >80% predicted forced vital capacity (FVC). Total of all reporting groups
Overall Number of Baseline Participants 80 26 47 153
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 26 participants 47 participants 153 participants
59.0  (11.7) 60.8  (11.4) 56.2  (11.2) 58.6  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 26 participants 47 participants 153 participants
Female
28
  35.0%
10
  38.5%
17
  36.2%
55
  35.9%
Male
52
  65.0%
16
  61.5%
30
  63.8%
98
  64.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 80 participants 26 participants 47 participants 153 participants
80 26 47 153
1.Primary Outcome
Title Acceptance Rate of Early Non-invasive Positive Pressure Ventilation (NIPPV) Treatment.
Hide Description Percentage of patients attempting to use NIPPV therapy within six weeks of initial offer.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not obtained from the "Standard of Care NIPPV and Nutritional Monitoring" arm.
Arm/Group Title Standard of Care NIPPV and Nutritional Monitoring Standard of Care NIPPV Early NIPPV Intervention
Hide Arm/Group Description:
Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status.
Participants with 50-74% predicted forced vital capacity (FVC).
Participants with >80% predicted forced vital capacity (FVC).
Overall Number of Participants Analyzed 0 26 47
Measure Type: Count of Participants
Unit of Measure: Participants
0
23
  88.5%
35
  74.5%
2.Other Pre-specified Outcome
Title Patient Survival With Early Versus Standard of Care NIPPV Treatment
Hide Description Duration of patient survival
Time Frame one year
Outcome Measure Data Not Reported
3.Other Pre-specified Outcome
Title Compliance With NIPPV Treatment
Hide Description Number of hours of NIPPV use per month
Time Frame one month
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Total Daily Energy Expediture (TDEE) of ALS Patients
Hide Description Total daily energy expenditure (TDEE) with be measured using the dual labeled water (DLW) method
Time Frame Duration of study (approximately 1 year)
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Tolerance of NIPPV Treatment
Hide Description Percent of patients achieving tolerance (>4hr/night NIPPV after 2-3 week titration period) determined by actual usage data.
Time Frame one month
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected for the "Standard of Care NIIPPV and Nutritional Monitoring" arm.
Arm/Group Title Standard of Care NIPPV and Nutritional Monitoring Standard of Care NIPPV Early NIPPV
Hide Arm/Group Description:
Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status.
Participants with 50-74% predicted forced vital capacity (FVC).
Participants with >80% predicted forced vital capacity (FVC).
Overall Number of Participants Analyzed 0 23 35
Measure Type: Count of Participants
Unit of Measure: Participants
0
11
  47.8%
14
  40.0%
Time Frame 3 years, 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combined Arms
Hide Arm/Group Description Sincere efforts were made to locate per arm data, but these data are no longer available. All adverse events are reported as one arm/group.
All-Cause Mortality
Combined Arms
Affected / at Risk (%)
Total   19/153 (12.42%)    
Show Serious Adverse Events Hide Serious Adverse Events
Combined Arms
Affected / at Risk (%) # Events
Total   42/153 (27.45%)    
Cardiac disorders   
Cardiac Arrest  [1]  1/153 (0.65%)  1
Irregular Heartbeat  [2]  2/153 (1.31%)  2
Myocardial Infarction  [3]  1/153 (0.65%)  1
Gastrointestinal disorders   
Colonic Bleed  [4]  1/153 (0.65%)  1
Dislodged PEG Tube  [5]  1/153 (0.65%)  1
Distended Abdomen  [6]  1/153 (0.65%)  1
Dysphagia  [7]  3/153 (1.96%)  3
PEG Procedure Complications  [8]  2/153 (1.31%)  2
Sepsis  [9]  1/153 (0.65%)  1
General disorders   
Death  [10]  14/153 (9.15%)  14
Infections and infestations   
Infection  [11]  2/153 (1.31%)  2
Metabolism and nutrition disorders   
Failure to Thrive  [12]  1/153 (0.65%)  1
Hypokalemia, hypomagnesia, and antythmia  [13]  1/153 (0.65%)  1
Musculoskeletal and connective tissue disorders   
Hip Fracture  [14]  1/153 (0.65%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Liver Cancer Diagnosis  [15]  1/153 (0.65%)  1
Transitional Cell Carcinoma  [16]  1/153 (0.65%)  1
Nervous system disorders   
ALS Progression  [17]  1/153 (0.65%)  1
Concussion  [18]  1/153 (0.65%)  1
Renal and urinary disorders   
Bladder malignancy/UTI  [19]  1/153 (0.65%)  1
Respiratory, thoracic and mediastinal disorders   
Aspiration  [20]  1/153 (0.65%)  1
Aspiration Pneumonia  [21]  1/153 (0.65%)  1
Blood Clot  [22]  1/153 (0.65%)  1
Difficulty Breathing  [23]  1/153 (0.65%)  1
Dyspnea  [24]  1/153 (0.65%)  1
Loculated right pleural effusion  [25]  1/153 (0.65%)  1
Pneumonia  [26]  4/153 (2.61%)  4
Pulmonary Emboli and pneumonia  [27]  1/153 (0.65%)  1
Respiratory Complications  [28]  2/153 (1.31%)  2
Respiratory Failure  [29]  2/153 (1.31%)  2
Shortness of Breath  [30]  2/153 (1.31%)  2
Skin and subcutaneous tissue disorders   
Laceration  [31]  1/153 (0.65%)  1
Subarachroid Hemmorrhage and Contusion  [32]  1/153 (0.65%)  1
Subdural Hematoma  [33]  1/153 (0.65%)  1
Surgical and medical procedures   
Peg Replacement  [34]  2/153 (1.31%)  2
Indicates events were collected by systematic assessment
[1]
Dates: 4/4/2006 4/4/2006 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to Study: Unrelated Description: Cardiac Arrest
[2]
Dates: 1/18/2008 2/17/2008 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Irregular Heartbeat
[3]
Dates: 8/30/2007 8/31/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Apparent Myocardial Infarction
[4]
Dates: 1/15/2007 1/29/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship: Unrelated Description: Left Colonic Bleed
[5]
Dates: 6/30/2007 Status: Continuing at discontinuation Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Dislodged PEG Tube and Respiratory Distress
[6]
Dates: 8/24/2005 8/29/2005 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Distended Abdomen
[7]
Dates: 3/11/2008 3/11/2008 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Dysphagia
[8]
Dates: 5/11/2006 5/12/2006 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to study: Unrelated Description: Complications from PEG Procedure
[9]
Dates: 10/3/2007 10/11/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Severe Sepsis around PEG Tube
[10]
Dates: 6/2/2006 6/2/2006 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to Study: Unrelated Description: No Information Given
[11]
Dates: 10/3/2007 10/11/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Severe infection
[12]
Dates: 7/23/2007 8/10/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Diagnosed as failure to thrive
[13]
Dates: 12/15/2007 12/17/2007 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Hypokalemia, hypomagnesia, and antythmia
[14]
Dates: 4/25/2006 5/4/2006 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to study: Unrelated Description: Left Hip Fracture Resulting From Fall
[15]
Dates: 11/4/2005 Status: Continuing at discontinuation Reason for Qualifying: Are other conditions which represent significant hazards Intensity: Severe Relationship to Study: Unrelated Description: Liver Cancer Diagnosis
[16]
Dates: 9/6/2007 9/23/2007 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to study: Unrelated Description Small bowel obstruction, transitional cell carcinoma
[17]
Dates: 5/5/2007 5/25/2007 Status: Resolved Reason for Qualifying: Are other conditions which represent significant hazards Intensity: Moderate Relationship to study: Unrelated Description: Treatment and Evaluation of ALS Progression
[18]
Dates: 2/7/2007 2/7/2007 Status: Resolved Reason for Qualifying: Life-threatening Intensity: Moderate Relationship to Study: Unrelated Description: Concussion as result of Automobile Accident
[19]
Dates: 8/22/2007 9/5/2007 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Possible bladder malignancy and UTI
[20]
Dates: 5/11/2008 5/12/2008 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Mild Relationship to study: Unrelated Description: Aspiration
[21]
Dates: 6/10/2007 6/19/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Presumed Aspiration Pneumonia
[22]
Dates: 8/21/2005 9/1/2005 Status:Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to study: Unrelated Description: Blood Clot Behind right knee
[23]
Dates: 5/21/2007 5/27/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Difficulty breathing due to Sialorrhea
[24]
Dates: 4/9/2007 Status: Continuing at discontinuation Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Increased Dyspnea
[25]
Dates: 7/27/2007 8/2/2007 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Loculated right pleural effusion and possible Pneumonia
[26]
Dates: 3/6/2008 3/19/2008 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Pneumonia
[27]
Dates: 9/3/2006 10/5/2006 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Pulmonary emboli and pneumonia
[28]
Dates: 10/7/2006 10/7/2006 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to study: Unrelated Description: Respiratory Complications
[29]
Dates: 9/28/2007 9/28/2007 Status: Resolved Reason for qualifying: Requiring or prolonging Hospitalization Intensity: Severe Relationship to study: Unrelated Description: continued respiratory decline
[30]
Dates: 10/2/2006 Status: Continuing at discontinuation Reason for Qualifying: Are other conditions which represent significant hazards Intensity: Severe Relationship: Unrelated Description: Shortness of breath
[31]
Dates: 9/9/2007 11/4/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Debridement and Closure of Laceration
[32]
Dates: 3/14/2007 3/16/2007 Status: Resolved Reason for Qualifying: Resulting in death Severe Relationship to Study: Unrelated Description: Sub-arachnoid Haemmorrhage and Contusion Resulting from fall
[33]
Dates: 6/11/2007 6/11/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Subdural Hematoma from fall
[34]
Dates: 3/14/2008 3/18/2008 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Mild Relationship to study: Unrelated Description: PEG replacement
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Combined Arms
Affected / at Risk (%) # Events
Total   62/153 (40.52%)    
Blood and lymphatic system disorders   
Edema  [1]  7/153 (4.58%)  7
Cardiac disorders   
Hypertension  [2]  1/153 (0.65%)  1
Hypotension  [3]  1/153 (0.65%)  1
Eye disorders   
Dry Eye  [4]  1/153 (0.65%)  1
Gastrointestinal disorders   
Abdominal Distension  [5]  3/153 (1.96%)  3
Constipation  [6]  8/153 (5.23%)  8
Decreased Rectal Tone  [7]  1/153 (0.65%)  1
Dehydration  [8]  1/153 (0.65%)  1
Dental  [9]  1/153 (0.65%)  1
Diarrhea  [10]  4/153 (2.61%)  6
Diverticulitis  [11]  1/153 (0.65%)  1
Dysphagia  [12]  1/153 (0.65%)  1
Gastritis  [13]  1/153 (0.65%)  1
PEG  [14]  3/153 (1.96%)  3
Sialorrhea  [15]  1/153 (0.65%)  3
Stomach Upset  [16]  3/153 (1.96%)  3
Urgent Bowel Movements  [17]  1/153 (0.65%)  1
Vomiting  [18]  1/153 (0.65%)  1
General disorders   
Burning Sensation  [19]  1/153 (0.65%)  1
Cold  [20]  7/153 (4.58%)  8
Fall  [21]  8/153 (5.23%)  9
Fatigue  [22]  5/153 (3.27%)  5
Pain  [23]  4/153 (2.61%)  6
Sore Throat  [24]  1/153 (0.65%)  2
Weight Loss  [25]  1/153 (0.65%)  1
Immune system disorders   
Allergy  [26]  2/153 (1.31%)  2
Congestion  [27]  2/153 (1.31%)  2
Post Nasal Drip  [28]  2/153 (1.31%)  2
Infections and infestations   
Conjunctivitis  [29]  2/153 (1.31%)  2
Ear Infection  [30]  1/153 (0.65%)  1
Infection  [31]  1/153 (0.65%)  1
Sinus Infection  [32]  1/153 (0.65%)  1
UTI  [33]  4/153 (2.61%)  5
Metabolism and nutrition disorders   
Abnormal Lab  [34]  8/153 (5.23%)  8
Hypercarbia  [35]  1/153 (0.65%)  1
Musculoskeletal and connective tissue disorders   
Ankle Sprain  [36]  1/153 (0.65%)  1
Arthritis  [37]  1/153 (0.65%)  1
Back Pain  [38]  4/153 (2.61%)  4
Fracture  [39]  1/153 (0.65%)  1
Knee Sprain  [40]  1/153 (0.65%)  1
Osteopenia  [41]  1/153 (0.65%)  1
Shoulder Pain  [42]  3/153 (1.96%)  3
Weakness  [43]  3/153 (1.96%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon Polyp  [44]  1/153 (0.65%)  1
Nervous system disorders   
Concussion  [45]  1/153 (0.65%)  1
Dizziness  [46]  3/153 (1.96%)  4
Hallucination  [47]  1/153 (0.65%)  1
Headache  [48]  2/153 (1.31%)  2
Renal and urinary disorders   
Urinary Frequency  [49]  1/153 (0.65%)  1
Respiratory, thoracic and mediastinal disorders   
Blood Clot  [50]  1/153 (0.65%)  1
Bronchitis  [51]  4/153 (2.61%)  4
Cough  [52]  1/153 (0.65%)  1
Nosebleed  [53]  1/153 (0.65%)  1
Pneumonia  [54]  1/153 (0.65%)  1
RADS  [55]  1/153 (0.65%)  1
Shortness of breath  [56]  2/153 (1.31%)  2
Spasm (Respiratory)  [57]  1/153 (0.65%)  1
Wheezing  [58]  1/153 (0.65%)  1
Skin and subcutaneous tissue disorders   
Blister  [59]  1/153 (0.65%)  1
Bruise  [60]  2/153 (1.31%)  2
Contusion  [61]  1/153 (0.65%)  1
Dermatitis  [62]  1/153 (0.65%)  1
Laceration  [63]  2/153 (1.31%)  3
Lesion  [64]  1/153 (0.65%)  1
Pressure Sores  [65]  1/153 (0.65%)  2
Rash  [66]  4/153 (2.61%)  4
Indicates events were collected by systematic assessment
[1]
Dates: 10/24/2006 Status: Unresolved at 48 Weeks Description: Edema Intensity: mild Relationship to study: not likely
[2]
Dates: 1/11/2008 Status: Unresolved at 48 Weeks Description: Hypertension Intensity: mild Relationship to study: not likely
[3]
Dates: 11/4/2006 11/4/2006 Status: Ended Description: Hypotension Intensity: mild Relationship to Study: not related
[4]
Dates: 10/15/2007 Description:Dry Eye Intensity: mild Relationship to study: probable
[5]
Dates: 3/20/2007 Status: Unresolved at 48 Weeks Description: Abdominal distension Intensity: moderate Relationship to study: possible
[6]
Dates: 2/1/2006 6/1/2006 Status: Resolved Description: Constipation Intensity: moderate Relationship to study: not likely
[7]
Dates: 6/4/2007 Status: Continuing Description: Decreased Rectal Tone Intensity: moderate Relationship to study: not related
[8]
Dates: 3/5/2008 Description: Dehydration Intensity: mild Relationship to study: not likely
[9]
Dates: 4/17/2006 Status: Ended Description: Dental Intensity: moderate Relationship to study: not related
[10]
Dates: 2/10/2007 2/10/2007 Status: Ended Description: Diarrhea Intensity: mild Relationship to study: not related
[11]
Dates: 10/15/2006 11/14/2006 Status: Resolved Description: Diverticulitis Intensity: severe Relationship to study: not related
[12]
Dates: 6/15/2006 Status: Unresolved at 48 Weeks Description: Dysphagia Intensity: mild Relationship to study: not likely
[13]
Dates: 9/25/2006 10/2/2006 Status: Ended Description: Gastritis Intensity: severe Relationship to study: not related
[14]
Dates: 6/29/2006 7/1/2006 Status: Ended Description: PEG Intensity: moderate Relationship to study: not related
[15]
Dates: 2/10/2006 Status: Unresolved at 48 Weeks Description: Sialorrhea Intensity: mild Relationship to study: not related
[16]
Dates: 4/29/2006 5/1/2006 Status: Ended Description: Stomach Upset Intensity: mild Relationship to study: not related
[17]
Dates: 2/1/2006 Status: Unresolved at Discontinuation Description: Urgent Bowel Movements Intensity: mild Relationship to study: possible
[18]
Dates: 10/18/2005 10/18/2005 Status: Ended Description: Vomiting Intensity: mild Relationship to study: not related
[19]
Dates: 7/23/2007 Status: Continuing Description: PAIN Burning Sensation Intensity: severe Relationship to study: not related
[20]
Dates: 8/9/2007 8/15/2007 Status: Ended Description: Cold Intensity: mild Relationship to study: not related
[21]
Dates: 4/13/2007 4/13/2007 Status: Ended Description: Fall Intensity: mild Relationship to study: not related
[22]
Dates: 11/1/2005 Status: Unresolved at Discontinuation Description: Fatigue Intensity: severe Relationship to study: not related
[23]
Dates: 11/20/2006 12/18/2006 Status: Resolved Description: Pain Intensity: moderate Relationship to study: not related
[24]
Dates: 10/12/2006 Status: Unresolved at 48 Weeks Description: Sore Throat Intensity: mild Relationship to study: not related
[25]
Dates: 8/8/2005 3/13/2006 Status: Ended Description: Weight Loss Intensity: moderate Relationship to study: not related
[26]
Dates: 4/17/2007 4/22/2007 Status: Ended Description: Allergy Intensity: mild Relationship to study: not related
[27]
Dates: 7/21/2006 7/31/2006 Status: Resolved Description: Congestion Intensity: moderate Relationship to study: not related
[28]
Dates: 3/31/2006 Status: Unresolved at 48 Weeks Description: Post Nasal Drip Intensity: severe Relationship to study: not related
[29]
Dates: 7/3/2007 7/8/2007 Status: Ended Description: Conjunctivitis Intensity: mild Relationship to study: not related
[30]
Dates: 10/1/2006 10/26/2006 Status: Resolved Description: Ear Infection Intensity: mild Relationship to study: not related
[31]
Dates: 10/26/2007 11/4/2007 Status: Ended Description: Infection Intensity: mild Relationship to study: not related
[32]
Dates: 4/1/2007 4/7/2007 Status: Ended Description: Sinus Infection Severity: moderate Relationship to study: not related
[33]
Dates: 3/14/2006 3/24/2006 Status: Ended Description: UTI Intensity: moderate Relationship to study: not related
[34]
Dates: 5/2/2006 8/21/2006 Status: Resolved Description: Abnormal Lab Intensity: mild Relationship to study: not related
[35]
Dates: 11/6/2006 Status: Continuing Description: Hypercarbia Intensity: mild Relationship to study: not related
[36]
Dates: 9/6/2006 Status: Ended Description: Ankle Sprain Intensity: moderate Relationship to study: not related
[37]
Dates: 3/27/2007 Status: Unresolved at 48 Weeks Description: Arthritis Intensity: mild Relationship to study: not related
[38]
Dates:: 6/3/2006 Status: Unresolved at 48 weeks Description: Back Pain Intensity: moderate Relationship to study: not related
[39]
Dates: 1/18/2007 3/29/2007 Status: Resolved Description: Fracture Intensity: mild Relationship to study: not related
[40]
Dates: 6/30/2007 7/13/2007 Status: Ended Description: Knee Sprain Intensity: moderate Relationship to study: not related
[41]
Dates: 9/4/2006 Status: Unresolved at 48 Weeks Description: Osteopenia Intensity: mild Relationship to study: not likely
[42]
Dates: 1/23/2006 1/25/2006 Status: Ended Description: Shoulder Pain Intensity: severe Relationship to study: not related
[43]
Dates: 2/1/2006 Status: Unresolved at Discontinuation Description: Weakness Intensity: mild Relationship to study: not related
[44]
Dates: 2/1/2006 2/1/2006 Status: Ended Description: Colon Polyp Intensity: mild Relationship: not related
[45]
Dates: 2/6/2006 2/6/2006 Status: Ended Description: Concussion Intensity: severe Relationship to study: not related
[46]
Dates: 1/15/2006 Status: Ended Description: Dizziness Intensity: moderate Relationship to study: not related
[47]
Dates: 9/13/2006 9/16/2006 Status: Ended Description: Hallucination Intensity: moderate Relationship to study: not related
[48]
Dates: 1/18/2006 3/1/2006 Status: Ended Description: Headache Intensity: mild Relationship to study: not related
[49]
Dates: 6/11/2007 6/24/2007 Status: Ended Description: Urinary Frequency Intensity: moderate Relationship to study: not likely
[50]
Dates: 1/28/2008 Status: Unresolved at 48 Weeks Description: Blood Clot Intensity: moderate Relationship to study: not related
[51]
Dates: 1/20/2008 2/10/2008 Status: Ended Description: Bronchitis Intensity: moderate Relationship to study: possible
[52]
Dates: 9/7/2006 Status: Ended Description: Cough Intensity: moderate Relationship: not related
[53]
Dates: 11/1/2007 Status: Continuing Description: Nosebleed Intensity: mild Relationship to study: probable
[54]
Dates: 11/1/2007 Status: Unresolved at 48 Weeks Description: Pneumonia Intensity: moderate Relationship to study: not related
[55]
Dates: 1/17/2007 4/30/2007 Status: Ended Description: RADS Intensity: mild Relationship: not related
[56]
Dates: 2/25/2007 2/25/2007 Status: Ended Description: Shortness of Breath Intensity: moderate Relationship to study: not related
[57]
Dates: 1/19/2007 1/19/2007 Status: Resolved Description: Spasm Intensity: mild Relationship to study: not related
[58]
Dates: 11/6/2006 Status: Resolved Description: Wheezing Intensity: moderate Relationship to study: not related
[59]
Dates: 4/1/2008 Status: Unresolved at 48 Weeks Description: Blister Intensity: mild Relationship to study: not related
[60]
Dates: 5/11/2006 5/11/2006 Status:Ended Description: Bruise Intensity: mild Relationship to study: not related
[61]
Dates: 7/4/2007 7/4/2007 Status: Ended Description: Contusion Intensity: mild Relationship to study: not related
[62]
Dates: 3/1/2008 Status: Unresolved at 48 Weeks Description: Dermatitis Intensity: mild Relationship to study: possible
[63]
Dates: 2/5/2007 2/5/2007 Status: Ended Description: Laceration Intensity: mild Relationship to study: not related
[64]
Dates: 3/30/2007 5/7/2007 Status: Ended Description: Lesion Intensity: mild Relationship to study: definite
[65]
Dates: 11/28/2006 11/30/2006 Status: Resolved Description: Pressure Sores Intensity: mild Relationship to study: not related
[66]
Dates: 8/15/2005 Status: Unresolved at 48 Weeks Description: Rash Intensity: mild Relationship to study: not likely
Compliance with NIPPV intervention is limited due to technical difficulties in obtaining BiPAP download data from some sites. This was due to variability in the local respiratory therapists engaged by commercial respiratory therapy companies.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Edward J. Kasarskis, M.D., Ph.D.
Organization: University of Kentucky
Phone: 859-218-5061
EMail: ejkas@uky.edu
Layout table for additonal information
Responsible Party: Edward Kasaraskis, University of Kentucky
ClinicalTrials.gov Identifier: NCT00116558     History of Changes
Other Study ID Numbers: R01NS045087 ( U.S. NIH Grant/Contract )
R01NS045087 ( U.S. NIH Grant/Contract )
First Submitted: June 29, 2005
First Posted: June 30, 2005
Results First Submitted: March 15, 2010
Results First Posted: July 31, 2019
Last Update Posted: July 31, 2019