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Sleep Disordered Breathing in Gulf War Illness and the Effect of Nasal CPAP Treatment

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ClinicalTrials.gov Identifier: NCT00252629
Recruitment Status : Completed
First Posted : November 11, 2005
Results First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Apnea, Sleep
Chronic Fatigue Syndrome
Intervention Other: Nasal CPAP treatment during sleep
Enrollment 29
Recruitment Details

18 male veterans with GWI and Sleep Disordered Breathing recruited by advertisement, they were splitter into a matched two groups: 9 veterans received active nasal CPAP and 9 veterans received sham nasal CPAP.

Additionally, we recruited asymptomatic 11 male veterans of Gulf war.

Pre-assignment Details  
Arm/Group Title Therapeutic Nasal CPAP Sham Nasal CPAP Comparison of IFL During Sleep in GWS and Healthy
Hide Arm/Group Description

Nine participants assigned to receive 3 weeks of treatment during sleep with therapeutic nasal CPAP.

Using validated questionnaires, fatigue, pain, and cognitive dysfunction were assessed by self-report before and after the three weeks treatment trial.

We compared the change of veterans reported outcomes "symptoms change" before and after 3 weeks treatment period on therapeutic nasal CPAP.

Nine participants assigned to receive 3 weeks of treatment during sleep with sham nasal CPAP.

Using validated questionnaires, fatigue, pain, and cognitive dysfunction were assessed by self-report before and after the three weeks treatment trial.

We compared the change of veterans reported outcomes "symptoms change" before and after 3 weeks treatment period on sham nasal CPAP.

We recruited 18 male veterans with GWS (same group that were randomized to receive CPAP treatment) and 11 asymptomatic male veterans of the first Gulf war.

All veterans had a polysomnography to determine the presence of sleep disordered breathing.

We compared the prevalence of Inspiratory Flow Limitation (IFL) during supine stage 2 sleep among both groups.

Period Title: Overall Study
Started 9 9 11 [1]
Completed 8 [2] 9 11 [1]
Not Completed 1 0 0
[1]
We used data from the 18 veterans with GWS in addition to the 11 control
[2]
One participant assigned to therapeutic CPAP was excluded from the trial before starting treatment.
Arm/Group Title Therapeutic Nasal CPAP Sham Nasal CPAP Healthy Asymptomatic Control Total
Hide Arm/Group Description The occurrence of the following 3 symptoms in a Gulf War veteran beginning after 8/90, lasting at least 6 months and present at the time of screening: fatigue that limits usual activity; musculoskeletal pain involving 2 or more regions of the body; and cognitive symptoms (memory, concentration, or attention difficulties). All 3 symptoms must be unexplained by any clearly defined organic illness. The occurrence of the following 3 symptoms in a Gulf War veteran beginning after 8/90, lasting at least 6 months and present at the time of screening: fatigue that limits usual activity; musculoskeletal pain involving 2 or more regions of the body; and cognitive symptoms (memory, concentration, or attention difficulties). All 3 symptoms must be unexplained by any clearly defined organic illness.

Eleven male veterans of first gulf war were screened for fatigue, pain and cognitive dysfunction by self report instrument.

They all score below the clinical thershold and assigned as healthy asymptomatic

Total of all reporting groups
Overall Number of Baseline Participants 9 9 11 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 11 participants 29 participants
41.4  (4.1) 42.9  (3.1) 41  (6.6) 42.2  (0.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 11 participants 29 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
9
 100.0%
9
 100.0%
11
 100.0%
29
 100.0%
1.Primary Outcome
Title Change of Fatigue Symptom
Hide Description Fatigue- increasing impact was rated 1-7 using the fatigue severity scale on days 1 and 7 averaged, where 1= no fatigue and 7= severe fatigue.
Time Frame 3 weeks treatment with either therapeutic or sham CPAP
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Nasal CPAP Sham Nasal CPAP
Hide Arm/Group Description:
Comparing the change of fatigue complaint before and after 3 weeks treatment of therapeutic nasal CPAP
Comparing the change of fatigue complaint before and after treatment of 3 weeks on sham nasal CPAP
Overall Number of Participants Analyzed 8 9
Mean (Standard Error)
Unit of Measure: units on a scale
2.1  (0.9) 0.2  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Therapeutic Nasal CPAP, Sham Nasal CPAP
Comments The change of fatigue complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title The Prevalence of Inspiratory Flow Limitation (IFL) During Sleep in GWS.
Hide Description

IFL was determined by plotting inspiratory flow against supra-glottic pressure for each breath sampled during continuous stage 2 sleep on a full night polysomnogram on both veterans with GWS and asymptomatic gulf war veterans.

We expressed the prevalence of inspiratory flow limitations during sleep as the percentage of flow limited breath in the sample of both GWS and asymptomatic gulf was veterans.

Time Frame On a full night polysomnogram
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GWS Male Group Asymptomatic Male Veterans of Gulf War.
Hide Arm/Group Description:

A group of18 male veterans with GWS were examined. Each participant underwent full night polysomnogram while sleeping supine using a standard clinical monitoring for sleep and breathing. Inspiratory flow was measured using pneumotachograph and respiratory effort measured with supra-glottis catheter.

Sampling of flow and effort during continuous stage 2 sleep was obtained and compared among both groups.

Inspiratory flow was plotted against effort for each breath. IFL was defined as a 1 cm H2O or greater decrease in supraglotic pressure without a corresponding increase in airflow of at least 5 ml/second.

The percentage of flow limited breath was calculated as the total number of flow limited breaths divided by the total breaths in all the samples.

A group of 11 asymptomatic male veterans of gulf war were examined. Each participant underwent full night polysomnogram while sleeping supine using a standard clinical monitoring for sleep and breathing. Inspiratory flow was measured using pneumotachograph and respiratory effort measured with supra-glottis catheter.

Sampling of flow and effort during continuous stage 2 sleep was obtained and compared among both groups.

Inspiratory flow was plotted against effort for each breath. IFL was defined as a 1 cm H2O or greater decrease in supraglotic pressure without a corresponding increase in airflow of at least 5 ml/second.

The percentage of flow limited breath was calculated as the total number of flow limited breaths divided by the total breaths in all the samples.

Overall Number of Participants Analyzed 18 11
Mean (Standard Deviation)
Unit of Measure: percentage of flow limited breaths
96  (5) 36  (25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GWS Male Group
Comments The p value was based on t-test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change of Pain Complaint
Hide Description

Pain- increased level were rated 0-10 by visual analogue scale, where 0= no pain and 10= severe pain.

We compared the change of pain symptom before and after treatment of either 3 weeks on therapeutic nasal CPAP or sham nasal CPAP

Time Frame 3 weeks of treatment on either therapeutic or sham nasal CPAP
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Nasal CPAP Sham Nasal CPAP
Hide Arm/Group Description:
Comparing the change of pain complaint before and after 3 weeks treatment of therapeutic nasal CPAP
Comparing the change of pain complaint before and after treatment of 3 weeks on sham nasal CPAP
Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (0.9) 0.4  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Therapeutic Nasal CPAP, Sham Nasal CPAP
Comments The change of pain symptom from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change of Cognitive Dysfunction
Hide Description Cognition dysfunction- increasing difficulty with memory, ability to think, and ability to concentrate was rated 0-10 daily by visual analogue scale, where 0 no problem and 10=severe problems.
Time Frame 3 weeks treatment with either therapeutic or sham CPAP
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Nasal CPAP Sham Nasal CPAP
Hide Arm/Group Description:
Comparing the change of cognitive dysfunction ( increasing difficulty with memory, ability to think, and ability to concentrate) complaints before and after 3 weeks treatment of therapeutic nasal CPAP
Comparing the change of cognitive dysfunction ( increasing difficulty with memory, ability to think, and ability to concentrate) complaints before and after 3 weeks treatment on sham nasal CPAP
Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (1.7) 0.4  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Therapeutic Nasal CPAP, Sham Nasal CPAP
Comments The change of cognitive dysfunction complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Therapeutic Nasal CPAP Sham Nasal CPAP Comparison of IFL During Sleep in GWS and Healthy
Hide Arm/Group Description Comparing change of veterans reported outcomes ( fatigue, pain and cognitive dysfunction) before and after 3 weeks treatment on therapeutic nasal CPAP with change of symptoms on sham nasal CPAP Comparing change of veterans reported outcomes ( fatigue, pain and cognitive dysfunction) before and after 3 weeks treatment on sham nasal CPAP with change of symptoms on therapeutic nasal CPAP

We recruited 11 asymptomatic male veterans of the first Gulf war. In addition to our 18 male veterans with GWS (same group that were randomized to receive CPAP treatment).

All veterans had a polysomnography to determine the presence of sleep disordered breathing.

We compared the prevalence of Inspiratory Flow Limitation (IFL) during supine stage 2 sleep among both groups.

All-Cause Mortality
Therapeutic Nasal CPAP Sham Nasal CPAP Comparison of IFL During Sleep in GWS and Healthy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Therapeutic Nasal CPAP Sham Nasal CPAP Comparison of IFL During Sleep in GWS and Healthy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Therapeutic Nasal CPAP Sham Nasal CPAP Comparison of IFL During Sleep in GWS and Healthy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%)   0/11 (0.00%) 
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: Mohammad M. Amin, MD
Organization: Northport, VAMC
Phone: 6312614400 ext 2469
EMail: mohammad.amin2@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00252629     History of Changes
Other Study ID Numbers: RCD-001-05S
First Submitted: November 9, 2005
First Posted: November 11, 2005
Results First Submitted: November 14, 2014
Results First Posted: December 11, 2014
Last Update Posted: December 11, 2014