Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03774810 |
| Other study ID # |
831801 |
| Secondary ID |
R01AG054521-01A1 |
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2019 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
University of Pennsylvania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
Phase-2: Baseline Period.
This phase lasts 14 days. Your participation includes:
- Completing daily sleep diaries at home. The online diary form requires about 5 minutes
each day to complete.
- Completing 6 to 7 forms asking questions about your medical symptoms, and sleep each
week of the baseline period. These online questionnaires require about 15 minutes to
complete.
- Abstaining from the use of any medication or over the counter product that is used
expressly for the purpose of helping you fall or stay asleep (e.g. trazadone/Desyrel,
melatonin, Nyquil, Tylenol PM, Benadryl, etc.). If you choose to discontinue your
current sleep medication to participate in our study, please do this in consultation
with the clinician that prescribed your sleep medication. Please note that
discontinuation of your current sleep medication will make it necessary to extend the
baseline component of our study by at least two weeks. Should the sleep diaries indicate
that your insomnia is not of the type, severity, or frequency required for the study,
you will not be able to continue in the study but will be provided with a referral. This
referral will be for the Penn Sleep Disorder Center. If you or study personnel deem your
two weeks to be unusual, you may be offered the chance to repeat the baseline period.
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:
- Taking a pill 30 minutes prior to bedtime. In one case, this will involve taking 1-3
pills per week. In the remaining conditions, pills will be taken on each and every
night. Depending on the specific group you are assigned to, you 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). Please note that the effect of zolpidem may
be slowed if taken with or immediately after a meal.
- 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.
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.
