Partial Reinforcement II
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 40 - 85 |
| Updated: | 1/23/2019 |
| Start Date: | April 15, 2019 |
| End Date: | June 30, 2022 |
| Contact: | Breanna D'Antonio, BS |
| Email: | bdant@upenn.edu |
| Phone: | 2157464378 |
Three Approaches to Maintenance Therapy for Chronic Insomnia in Older Adults
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.
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.
Inclusion Criteria:
- Patients with chronic insomnia will meet DSM-5 criteria for Insomnia Disorder, ICSD-3,
and RDC criteria for Psychophysiologic Insomnia. In addition, all subjects will have a
sleep initiation and/or a sleep maintenance complaint (> 30 min. to fall asleep and/or
> 30 min. of wakefulness during the night) with a problem frequency > 3 nights/wk and
problem duration > 3 mo. This profile must be evident at both intake (based on
retrospective reports) and as an average profile from the two weeks of baseline
diaries (prospective sampling).
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, and/or current experience, or history, of parasomnias (within the last 5
years).
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Michael Perlis, PhD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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