Combined Behavioral and Pharmacologic Therapy for Insomnia

(PRECEPT-D Trial)

Overseen By Ali A El-Solh, MD MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: VA Office of Research and Development

Must not be taking: Cytochrome inhibitors

Disqualifiers: Narcolepsy, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

52 Participants Needed

Trial Summary

What is the purpose of this trial?

Obstructive sleep apnea (OSA) is commonly reported in Veterans with post-traumatic stress disorder, which can potentiate symptoms of anxiety and depression, daytime symptoms and worsen nightmares. Continuous positive airway pressure (CPAP) is the most effective therapy but adherence to treatment is suboptimal. Insomnia is considered a barrier to long-term adherence. The overarching theme of the proposal is to compare the effectiveness of cognitive behavioral therapy for insomnia (CBT) plus eszopiclone, a nonbenzodiazepine hypnotic, versus CBT alone in Veterans with PTSD who are diagnosed with both OSA and insomnia, using a randomized, clinical trial, on sleep quality of life, PTSD severity, and CPAP adherence.

Research Team

Ali A El-Solh, MD MPH

Principal Investigator

VA Western New York Healthcare System, Buffalo, NY

Eligibility Criteria

This trial is for Veterans with PTSD, aged 18-65, who have both obstructive sleep apnea and chronic insomnia. They must be stable on psychotherapeutic treatments and not adherent to CPAP therapy. Exclusions include significant liver issues, eszopiclone sensitivity, pain-related insomnia, alcohol overuse, certain psychiatric or substance abuse disorders.

Inclusion Criteria

My mental health treatment has been stable for over a month.

You have been diagnosed with obstructive sleep apnea and don't use a CPAP machine for at least 4 hours every night.

I have been diagnosed with PTSD by a specialized clinic.

Exclusion Criteria

I am receiving treatment for seizures.

I have a history of serious liver problems.

My insomnia is caused by pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BBTI plus eszopiclone or BBTI alone over a period of 4 weeks

4 weeks

4 sessions of BBTI

Follow-up

Participants are monitored for changes in sleep quality, PTSD symptoms, and CPAP adherence

6 months

Treatment Details

Interventions

• Brief Behavioral Therapy for Insomnia
• Eszopiclone

Trial Overview The study tests if combining cognitive behavioral therapy (CBT) for insomnia with a sleeping pill called eszopiclone improves sleep quality, PTSD severity, and adherence to CPAP treatment in Veterans compared to CBT alone.

Participant Groups

Group I: BBTI plus eszopiclone Experimental Treatment 2 Interventions

participants randomized to the combination therapy will receive eszopiclone 2 mg orally at bedtime or placebo starting with the BBTI sessions for a period of 2 weeks in combination with 4 sessions of BBTI over 4 weeks.

Group II: BBTI Active Control 1 Intervention

participants randomized to BBTI will receive 4 sessions of BBTI over 4 weeks.

Brief Behavioral Therapy for Insomnia is already approved in United States for the following indications:

Approved in United States as BBT-I for:

• Insomnia
• Postconcussive symptoms in Mild Traumatic Brain Injury

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+