Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia (R01)
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|ClinicalTrials.gov Identifier: NCT03774810|
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : July 7, 2020
|First Submitted Date ICMJE||December 10, 2018|
|First Posted Date ICMJE||December 13, 2018|
|Last Update Posted Date||July 7, 2020|
|Actual Study Start Date ICMJE||April 15, 2019|
|Estimated Primary Completion Date||June 30, 2022 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Insomnia Relapse [ Time Frame: 1 year ]
Tracking Relapse via assessing daily sleep diary responses.
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
||Sleep Continuity [ Time Frame: 1 year ]
Assess sleep continuity by assessing daily sleep diary responses.
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia|
|Official Title ICMJE||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).
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.
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:
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.
Phase-2: Baseline Period.
This phase lasts 14 days. Your participation includes:
Phase-3: Sleep Lab Study (polysomnography) or Home Sleep Apnea Test (HSAT). You will undergo a polysomnography study or an HSAT to determine if you are eligible to continue in the study. During the pandemic all sleep tests will be administered at home. After the pandemic, the study investigators will decide which type of study you will receive. Both sleep assessments will last for 1 night.
The HSAT equipment will be shipped to your house. A member of the study team will contact you to go over proper use instructions. On the night of the test, you can go to bed at your regular bedtime. Prior to bedtime, you will attach the sensor(s) as instructed and start the test. Upon waking up, you will stop the test and remove the sensor(s). On the day immediately following the sleep test, you will ship the device back in the prepaid shipping envelope Procedures for the polysomnography study are: you will be asked to arrive at the sleep lab located at the Hospital of the University of Pennsylvania (HUP) at the cross streets of 34th and Spruce by 7 P.M. for a polysomnographic study (PSG). Upon arrival, to ensure for accurate laboratory measurements, urine toxicology screens may be performed to rule out illegal substance use. These data are acquired to explain abnormal findings on the PSG. Following the sleep study, it will be determined whether a repeat study is necessary based on the findings both from the clinical chemistries and the polysomnography. If a repeat study is necessary, one of the project investigators will discuss the issue of substance use with you to: (1) determine if the clinical chemistries' finding was an error (for example poppy seeds led to a positive screen) or (2) gain your willingness to refrain from substance use for the second PSG and for the remainder of the study. If you screen positive a second time, your participation will be discontinued.
The specific procedure for a PSG requires that you have a set of sensors placed on your face, scalp, and body by a technician. All the sensors are attached with surgical tape, paste and glue. The sensors on your face are attached on your left and right temple, cheek bone and under your nose. The sensors on the temple and cheek bone measure eye movements associated with falling asleep and dreaming. The sensors under your nose measure airflow through your mouth and nose. The sensors on your scalp measure brain waves during sleep. The sensors on the body are placed above the collar bones and over the calf muscles. The sensors over the collar bones measure heart muscle activity. The sensors over the calf muscles measure muscle activity from the legs. In addition, a strap will be placed around your chest and abdomen to measure respiration.
After you have been connected to the equipment, you are expected to stay in bed until final wake time the next morning, except for bathroom breaks. You will be visually monitored by the lab technicians by remote video. In the morning, you will be awakened by the technician (if needed), be unhooked from the equipment, and then allowed to shower, dress, and eat before leaving. You will be free to go about your normal schedule for the rest of the day.
If the in-lab PSG sleep or HSAT study finds evidence of a sleep disorder other than insomnia, such as sleep apnea, you will not be able to continue in the study but will be provided with a referral.
Phase-4: Standard Treatment. All participating subjects will receive one month of standard nightly treatment. If you have a positive treatment response you will remain in the study and be randomized to one of the following treatment conditions: nightly dosing, intermittent dosing (1-3 pills week, full dose), or one of two variable dose conditions (nightly pill use where any given pill is a variable dose). The assignment of condition will be accomplished by a process that is the same as the flip of a coin and neither you nor the study personnel will know which condition you have been assigned to (this is referred to as a "double blind" study). You will have an equal chance of being randomized to each of the 4 study arms. In the case of an emergency, the blind will be broken and the study doctor and clinicians associated with your care will be informed of which dosing condition you were assigned to.
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:
If you do not experience a treatment response or (following a treatment response) you experience a relapse of insomnia, you will not be able to 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 your clinical status (how your insomnia is responding to treatment) will be based on your daily sleep diaries and weekly questionnaires.
During Phase-4, you will be asked to undergo quarter annual physicals so that we can optimally track your health and wellbeing. The physicals will involve standard vital measures (e.g., temperature, blood pressure, height and weight, etc.) and, based on the judgement of the research clinician, may involve an EKG and/or blood and urine chemistries.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Double BlindedPrimary Purpose: Treatment
|Intervention ICMJE||Drug: Zolpidem tartrate
Zolpidem Tartrate, 5mg for men older than 60 and women of all ages. 10 mg for men younger than 60.
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||June 30, 2022|
|Estimated Primary Completion Date||June 30, 2022 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||40 Years to 85 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT03774810|
|Other Study ID Numbers ICMJE||831801
R01AG054521-01A1 ( U.S. NIH Grant/Contract )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||University of Pennsylvania|
|Study Sponsor ICMJE||University of Pennsylvania|
|PRS Account||University of Pennsylvania|
|Verification Date||July 2020|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP