Trial Outcomes & Findings for Sleep Disordered Breathing in Gulf War Illness and the Effect of Nasal CPAP Treatment (NCT NCT00252629)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

3 weeks treatment with either therapeutic or sham CPAP

Results posted on

2014-12-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Therapeutic Nasal CPAP 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.	Sham 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.	Comparison of IFL During Sleep in GWS and Healthy 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.
Overall Study STARTED	9	9	11
Overall Study COMPLETED	8	9	11
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Therapeutic Nasal CPAP n=9 Participants 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.	Sham Nasal CPAP n=9 Participants 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.	Healthy Asymptomatic Control n=11 Participants 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 n=29 Participants Total of all reporting groups
Age, Continuous	41.4 years STANDARD_DEVIATION 4.1 • n=5 Participants	42.9 years STANDARD_DEVIATION 3.1 • n=7 Participants	41 years STANDARD_DEVIATION 6.6 • n=5 Participants	42.2 years STANDARD_DEVIATION 0.7 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	29 Participants n=4 Participants

PRIMARY outcome

Timeframe: 3 weeks treatment with either therapeutic or sham CPAP

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.

Outcome measures

Outcome measures
Measure	Therapeutic Nasal CPAP n=8 Participants Comparing the change of fatigue complaint before and after 3 weeks treatment of therapeutic nasal CPAP	Sham Nasal CPAP n=9 Participants Comparing the change of fatigue complaint before and after treatment of 3 weeks on sham nasal CPAP
Change of Fatigue Symptom	2.1 units on a scale Standard Error 0.9	0.2 units on a scale Standard Error 1.0

PRIMARY outcome

Timeframe: On a full night polysomnogram

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.

Outcome measures

Outcome measures
Measure	Therapeutic Nasal CPAP n=18 Participants Comparing the change of fatigue complaint before and after 3 weeks treatment of therapeutic nasal CPAP	Sham Nasal CPAP n=11 Participants Comparing the change of fatigue complaint before and after treatment of 3 weeks on sham nasal CPAP
The Prevalence of Inspiratory Flow Limitation (IFL) During Sleep in GWS.	96 percentage of flow limited breaths Standard Deviation 5	36 percentage of flow limited breaths Standard Deviation 25

SECONDARY outcome

Timeframe: 3 weeks of treatment on either therapeutic or sham nasal CPAP

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

Outcome measures

Outcome measures
Measure	Therapeutic Nasal CPAP n=8 Participants Comparing the change of fatigue complaint before and after 3 weeks treatment of therapeutic nasal CPAP	Sham Nasal CPAP n=9 Participants Comparing the change of fatigue complaint before and after treatment of 3 weeks on sham nasal CPAP
Change of Pain Complaint	2.0 units on a scale Standard Deviation 0.9	0.4 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 3 weeks treatment with either therapeutic or sham CPAP

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.

Outcome measures

Outcome measures
Measure	Therapeutic Nasal CPAP n=8 Participants Comparing the change of fatigue complaint before and after 3 weeks treatment of therapeutic nasal CPAP	Sham Nasal CPAP n=9 Participants Comparing the change of fatigue complaint before and after treatment of 3 weeks on sham nasal CPAP
Change of Cognitive Dysfunction	2.0 units on a scale Standard Deviation 1.7	0.4 units on a scale Standard Deviation 1.0

Adverse Events

Therapeutic Nasal CPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Nasal CPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparison of IFL During Sleep in GWS and Healthy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mohammad M. Amin, MD

Northport, VAMC

Phone: 6312614400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place