Use of Armodafinil for Fatigue in Sarcoidosis
Status: | Completed |
---|---|
Conditions: | Insomnia Sleep Studies, Other Indications, Endocrine |
Therapuetic Areas: | Endocrinology, Psychiatry / Psychology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | October 2007 |
End Date: | August 2011 |
Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
The study will be divided into two halves. Patients will receive either drug or placebo in
the first half. Patients receiving active drug will be started at one dose and it can be
increased at the second visit. Those patients randomized to placebo will also have their dose
adjusted by the investigating physician. The physicians will be blinded as to whether the
patient is receiving drug or placebo. In the second half of the study, patients will receive
the opposite treatment.
Patients will have complete detailed questionnaires regarding their fatigue, sleepiness, and
overall quality of life.
They will have sleep studies done at the start and after each half of the study to determine
the effect of therapy on sleepiness.
the first half. Patients receiving active drug will be started at one dose and it can be
increased at the second visit. Those patients randomized to placebo will also have their dose
adjusted by the investigating physician. The physicians will be blinded as to whether the
patient is receiving drug or placebo. In the second half of the study, patients will receive
the opposite treatment.
Patients will have complete detailed questionnaires regarding their fatigue, sleepiness, and
overall quality of life.
They will have sleep studies done at the start and after each half of the study to determine
the effect of therapy on sleepiness.
Inclusion Criteria:
- Diagnosis of sarcoidosis using standard criteria 15.
- Disease for more than one year
- On stable, systemic therapy
- Complain of fatigue which has been present for more than six months.
- Over 18 years of age
- Provide written informed consent.
Exclusion Criteria:
- Pregnancy
- Change in therapy for sarcoidosis in prior three months
- History of ventricular arrythmias
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