Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI

NCT ID: NCT02458469

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-14
• Study Completion Date: 2019-04-12

Brief Summary

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.

Detailed Description

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).

Conditions

Spinal Cord Injury; Sleep Disordered Breathing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Buspirone

This drug will be taken for two week period

Group Type: ACTIVE_COMPARATOR

Buspirone

Intervention Type: DRUG

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.

Trazodone

This drug will be taken for two week period

Group Type: ACTIVE_COMPARATOR

Trazodone

Intervention Type: DRUG

100 mg dose before bed-time

Placebo

A placebo pill will be taken at bed time for two week period

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One placebo pill before bed-time

Interventions

Buspirone

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.

Intervention Type: DRUG

Trazodone

100 mg dose before bed-time

Intervention Type: DRUG

Placebo

One placebo pill before bed-time

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults with SCI (>6months after spinal cord injury) at the T6 level/above

Exclusion Criteria

• Pregnant and lactating females
• Heart failure, vascular disease, or stroke
• Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic kidney disease
• BMI >38 kg/m2
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abdulghani Sankari, MD PhD

Role: PRINCIPAL_INVESTIGATOR

John D. Dingell VA Medical Center, Detroit, MI

Locations

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1IK2CX000547

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NURC-062-12S

Identifier Type: -

Identifier Source: org_study_id