Sleep DisturbancePhase 4NCT03307005

Improving Sleep Quality in Heart Failure

A Phase 4 study testing Zolpidem Tartrate in people with Sleep Disturbance and Heart Failure, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 79 years
Conditions the study is for: Sleep Disturbance, Heart Failure
What is being tested?: Zolpidem Tartrate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2017to 25 Jan 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 21-79 years old
HFrEF, EF ≤ 45% (by echocardiography)
NYHA functional class I to III
Able to give written consent
On goal-directed medical therapy for HF, with stable dosing of HF medications for 2 weeks prior to enrollment
No hospitalizations for HF within the past month

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Positive response to experiencing any of the following sleep-related symptoms at least once a week:
Difficulty falling asleep
Waking up during the night and having difficulty getting back to sleep
Waking up too early in the morning and being unable to get back to sleep.

Who cannot join

Use of sedative-hypnotics, anxiolytic, or benzodiazepines within the previous 2 weeks
Current treatment with other sedating medications such as opioids
On therapy for pharmacological therapy for depression
History of alcohol/drug dependence
History of liver disease, HIV, or severe COPD
On Thorazine

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Current use of ketoconazole
Current use of tricyclic antidepressants
Current use of macrolide antibiotics
Current use of anticonvulsant medications
Pregnancy. A urine pregnancy test will be performed to exclude pregnancy in potential subjects.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Bayview Campus, Asthma and Allergy Center
Baltimore, Maryland, 21224

Other trials in United States

About this study

Poor sleep quality is common in patients with heart failure. The limited available evidence intimates that improving sleep quality in patients with heart failure may improve morbidity and quality of life in this patient population. However, there is a paucity of evidence assessing the use of effective pharmacologic therapies in heart failure. The nonbenzodiazepine, GABA receptor agonist, zolpidem, has been found to have considerable benefits over traditional benzodiazepines as a soporific medication. The investigators hypothesize that zolpidem will safely improve sleep quality in patients with heart failure.

Conditions: Sleep Disturbance, Heart Failure
Being tested: Zolpidem Tartrate, Placebo oral capsule
Medical subject headings: Parasomnias, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zolpidem TartrateDrug
Zolpidem tartrate 5 mg capsule one per night taken for 7 nights
Placebo oral capsuleDrug
Placebo capsule one per night taken for 7 nights

Study groups in NCT03307005
Study group	Role	What they receive
Intervention	Experimental	Not described Receives: Drug: Zolpidem Tartrate
Control	Placebo comparator	Not described Receives: Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Sleep Latency
Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.
Measured: 1 week
Total Sleep Time
Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.
Measured: 1 week
Sleep Efficiency
Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201725 Jan 2019

First posted11 Oct 2017
Study start1 Nov 2017
Primary completion25 Jan 2019
Study completion25 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single-site, randomized, parallel, placebo controlled, double blind study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03307005
Sponsor's protocol ID: IRB00142395
Status last verified: Feb 2020
First submitted: 28 Sep 2017
Last updated: 11 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sleep Disturbance trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Sleep Quality in Heart Failure
ClinicalTrials.gov ID: NCT03307005
Acronym / sponsor ID: IRB00142395
Conditions: Sleep Disturbance, Heart Failure
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: 1 Nov 2017 (actual)
Primary completion: 25 Jan 2019 (actual)
Study completion: 25 Jan 2019 (actual)
First posted: 11 Oct 2017 (actual)
Results: Posted 11 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Single-site, randomized, parallel, placebo controlled, double blind study

Arm	Type	Receives
Intervention	Experimental	Drug: Zolpidem Tartrate
Control	Placebo comparator	Drug: Placebo oral capsule

Who may qualify

Ages: 21 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age 21-79 years old
HFrEF, EF ≤ 45% (by echocardiography)
NYHA functional class I to III
Able to give written consent
On goal-directed medical therapy for HF, with stable dosing of HF medications for 2 weeks prior to enrollment

Key exclusion criteria (11 listed)

Use of sedative-hypnotics, anxiolytic, or benzodiazepines within the previous 2 weeks
Current treatment with other sedating medications such as opioids
On therapy for pharmacological therapy for depression
History of alcohol/drug dependence
History of liver disease, HIV, or severe COPD

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zolpidem TartrateZolpidem tartrate 5 mg capsule one per night taken for 7 nights	Drug	Intervention
Placebo oral capsulePlacebo capsule one per night taken for 7 nights	Drug	Control

Primary outcome

Sleep Latency
Time frame: 1 week
Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.
Total Sleep Time
Time frame: 1 week
Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.
Sleep Efficiency
Time frame: 1 week
Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.

Results and safety

Results posted to the registry on 11 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zolpidem Tartrate	3	3
Placebo	2	2

Primary outcome: Sleep Latency

Time frame: 1 week. Mean (Full Range). Unit: minutes

Measure	Intervention n = 3	Control n = 2
Value	-73.3 (-143 to 0.2)	21.9 (-5.5 to 49.1)

Primary outcome: Total Sleep Time

Time frame: 1 week. Mean (Full Range). Unit: minutes

Measure	Intervention n = 3	Control n = 2
Value	67.8 (36.5 to 125.3)	-87.3 (-184.5 to 10)

Primary outcome: Sleep Efficiency

Time frame: 1 week. Mean (Full Range). Unit: sleep efficiency percentage

Measure	Intervention n = 3	Control n = 2
Value	7.3 (0 to 17)	-5.5 (-33 to 22)

Adverse events

Time frame: 15 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Control	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rashmi Aurora, MD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zolpidem Tartrate in people with Sleep Disturbance and Heart Failure, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Latency (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03307005.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.