Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Hospital, Orthopedic |
| Therapuetic Areas: | Psychiatry / Psychology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/4/2018 |
| Start Date: | May 14, 2015 |
| End Date: | April 1, 2019 |
| Contact: | Abdulghani Sankari, MD PhD |
| Email: | Abdulghani.Sankari@va.gov |
| Phone: | (313) 576-1000 |
Pathogenesis of Sleep Disordered Breathing in Spinal Cord Injury Patients
The purpose of this study is to look at the effect of exciting using drugs to target a
specific pathway in the body, that relies on a natural chemical the body produces called
'serotonin', in patients with spinal cord injury (SCI) during sleep. During this part of the
study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone
(100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of
time followed by two weeks without drugs (washout period). The drugs will not be taken all at
the same time, but each will be taken separately for two weeks followed by a night study to
look at the effect the medication/placebo pill has on the way the body responds during sleep.
specific pathway in the body, that relies on a natural chemical the body produces called
'serotonin', in patients with spinal cord injury (SCI) during sleep. During this part of the
study participants will be asked to take buspirone (Buspar) (15-50mg per day), trazodone
(100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of
time followed by two weeks without drugs (washout period). The drugs will not be taken all at
the same time, but each will be taken separately for two weeks followed by a night study to
look at the effect the medication/placebo pill has on the way the body responds during sleep.
Randomized placebo controlled cross-over study. Each subject will be studied on three
separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; the patients will be
blinded to whether they are taking trazodone or placebo; buspirone cannot be blinded because
it is dosed twice a day and is up titrated during the two weeks of administration. The
initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic
response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a
maximum dose 30mg/day is reached. After the two week treatment a sleep study will be
repeated. Trazodone will be given at 100 mg dose before bed-time. (2) Cross over medication
for two weeks will be followed by a second sleep study followed by two weeks washout. (3)
Cross over medication for two weeks will be followed by another sleep study. To assess the
clinical effect of the drug on breathing during sleep a qualitative polysomnography will be
performed for 2 hours the same night after taking the drug/placebo. This will allow the
determination of ventilatory changes and the determination of the number of respiratory
events (apnea/hypopnea index).
separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; the patients will be
blinded to whether they are taking trazodone or placebo; buspirone cannot be blinded because
it is dosed twice a day and is up titrated during the two weeks of administration. The
initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic
response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a
maximum dose 30mg/day is reached. After the two week treatment a sleep study will be
repeated. Trazodone will be given at 100 mg dose before bed-time. (2) Cross over medication
for two weeks will be followed by a second sleep study followed by two weeks washout. (3)
Cross over medication for two weeks will be followed by another sleep study. To assess the
clinical effect of the drug on breathing during sleep a qualitative polysomnography will be
performed for 2 hours the same night after taking the drug/placebo. This will allow the
determination of ventilatory changes and the determination of the number of respiratory
events (apnea/hypopnea index).
Inclusion Criteria:
- Adults with SCI (>6months after spinal cord injury) at the T6 level/above
Exclusion Criteria:
- Pregnant and lactating females
- Demyelinating SCI
- Heart failure, vascular disease, or stroke
- History of head trauma ->loss of consciousness >24h
- Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic
kidney disease
- BMI >38 kg/m2
- Blood pressure at rest > 160 /95 mmHg
- Mechanical ventilation dependence
- The following medications are not allowed (potential interaction with buspirone or
inhibition of the CYP3A4 system):
- cimetidine
- ketoconazole
- ritonavir
- itraconazole
- erythromycin
- diltiazem
- verapamil
- Monoamine oxidase (MAO) inhibitors [such as Marplan, Nardil, Parmate, Emsam]
- Other prohibited concomitant medications include haloperidol, trazodone, or
triazolam
We found this trial at
1
site
Detroit, Michigan 48201
Principal Investigator: Abdulghani Sankari, MD PhD
Phone: 313-576-1000
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