Three Approaches to Maintenance Therapy for Chronic Insomnia in Older Adults
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 197
- Locations
- 1
- Primary Endpoint
- Treatment Response (Phase 1)
Study Overview
Brief Summary
The study is a three phase sequential study of the medical treatment of insomnia with zolpidem. All participating subjects will receive one month of standard nightly treatment. If the subject has a positive treatment response they continue in the study and are randomized to one of four conditions: intermittent dosing (3-5 pills week, full dose), or one of three variable dose conditions (nightly pill use where any given pill is a variable dose). Standard treatment will last for 4 weeks. The experimental phase will extend over two periods. The first period will last for 12 weeks. The second period will last for 36 weeks. Both periods include:
• Taking a pill 30 minutes prior to bedtime.
In one case, this will involve taking 3-5 pills per week. In the remaining condition pills will be taken on each and every night. Depending on the specific group that the subject is assigned to, they will either receive 10mg or 5mg of zolpidem (variable by age and sex) or a variable dose of zolpidem on a nightly basis (range from 0 mg to 10 mg per night).
- Completing a sleep diary each day;
- Completing 6 to 7 questionnaires each week;
- A monthly visit to Penn to return your medication foil packs and to receive a new foil pack with the next month of medication.
During Phases 3&4, the subject will be asked to undergo quarter annual physicals so that we can optimally track their health and wellbeing. The physicals will involve standard vitals measures (e.g., temperature, blood pressure, height and weight, etc.) and, based on the judgement of the research clinician, may involve an EKG and blood and urine chemistries.
If the subject does not experience a treatment response or (following a treatment response) experiences a relapse of insomnia, they will not continue in the study but will be given the opportunity to be treated with Cognitive Behavioral Therapy for Insomnia (CBT-I) at no cost. Assessments of the subjects clinical status will be based on your daily sleep diaries and weekly questionnaires.
Detailed Description
Phase-1: Initial Evaluation.
This evaluation occurs at the offices of the Behavioral Sleep Medicine Program (Suite 670, 3535 Market Street Philadelphia, PA 19104) and lasts about 1 to 2 hours. Procedures include:
- Completing forms asking questions about your sleep, mood, alcohol use, medical history, your current medications, and background questions about your age, race, and education.
- The provision of your consent to contact your primary care provider to gain their assent (agreement) that you may participate in the trial safely.
The information obtained during the initial assessment will be used to see if you are eligible to participate in this study. If you are determined ineligible, you will not be able to continue in the study but will be provided with a referral if appropriate.
NOTE: This study will be using an Internet Data Portal (IDP) system to collect most questionnaire data. The IDP is a Research Electronic Data Capture and is a secure web application. It is a password protected site located on Penn's servers in which the data will live in a database online where only qualified research personnel can access it. During the initial evaluation you will be introduced to this system and provided with a username and password. The study staff will assist you in filling out the questionnaires using this IDP system.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double Blinded
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Meet DSM-5 criteria for Insomnia Disorder, ICSD-3, and RDC criteria for Psychophysiologic Insomnia
- •Age 40-85
Exclusion Criteria
- •currently in treatment for insomnia
- •unstable medical or psychiatric illness
- •a history of treatment failure with zolpidem
- •discontinuation of zolpidem owing to side effects
- •current experience, or history, of parasomnias (within the last 5 years)
Arms & Interventions
Continuous
Nightly active dose (QHS). The intervention is zolpidem tartrate 5 mg or 10 mg.
Intervention: Zolpidem tartrate (Drug)
Partial Reinforcement 1
1 active dose per week with 6 placebos interspersed between the active dose. The intervention is zolpidem tartrate 5 mg or 10 mg.
Intervention: Zolpidem tartrate (Drug)
Partial Reinforcement 3
3 active doses per week with 4 placebos interspersed between the active doses. The intervention is zolpidem tartrate 5 mg or 10 mg.
Intervention: Zolpidem tartrate (Drug)
Low Frequency Intermittent Dosing
1 to 3 active doses per week, on night chosen by participant (as needed). The intervention is zolpidem tartrate 5 mg or 10 mg.
Intervention: Zolpidem tartrate (Drug)
Outcomes
Primary Outcomes
Treatment Response (Phase 1)
Time Frame: 1 Month
Tracking treatment response via assessing daily sleep continuity (sleep latency, wake after sleep onset, and early morning awakenings).
Insomnia Relapse (Phase 2)
Time Frame: 3 months
Tracking relapse via assessing daily sleep continuity (sleep latency, wake after sleep onset, and early morning awakenings).
Insomnia Relapse (Phase 3)
Time Frame: 9 months
Tracking relapse via assessing daily sleep continuity (sleep latency, wake after sleep onset, and early morning awakenings).
Secondary Outcomes
- Sleep Continuity (Phase 1)(1 Month)
- Sleep Continuity (Phase 2)(3 months)
- Sleep Continuity (Phase 3)(9 months)