CLINICAL TRIAL

Sleepwell for Sleeplessness

Waitlist Available · 65+ · All Sexes · Fredericton, Canada

This study is evaluating whether a set of activities can reduce the use of sleeping pills in people with dementia.

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About the trial for Sleeplessness

Eligible Conditions
Sleep Initiation and Maintenance Disorders · Insomnia Chronic

Treatment Groups

This trial involves 2 different treatments. Sleepwell is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Sleepwell
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Empower
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 65 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
long-term user of BZRA: use 3 months or longer
Insomnia is a common side-effect of BZRA. show original
People who live in New Brunswick, Canada. show original
age 65 or older
community dwelling with no anticipated change of address for the next 6 months
People who have taken Sleeping Pills (BZRAs) three or more times in the last week. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Sleepwell will improve 1 primary outcome, 3 secondary outcomes, and 13 other outcomes in patients with Sleeplessness. Measurement will happen over the course of baseline, 6 mo..

Score on the Quality of life SF-12v2
BASELINE, 6 MO.
Time to fall asleep (minutes)
BASELINE, 6 MO.
Sleep onset latency (SOL) measured in minutes
Number of participants discontinuing BZRA treatment within 3 months
3 MONTHS
Number of participants reporting having a fall (subjective)
BASELINE, 6 MONTHS
Score on the Epworth Sleepiness Scale
BASELINE, 6 MONTHS
Assessment of daytime sleepiness
Score on the Beliefs about Medicines Questionnaire (BMQ)
BASELINE, 6 MONTHS
BMQ
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How serious can sleeplessness be?

Sleeplessness is a serious problem but we also need to recognise that not everyone is affected in the same way on any one occasion. The severity of problems that arise depend largely on the personality in question and the social and other factors that he or she may not have control over, on each occasion.

Anonymous Patient Answer

What are common treatments for sleeplessness?

Many chronic insomnia sufferers have trouble falling asleep at night, and wake up during the night. Sleep aids like melatonin can be helpful. However, in severe cases, a short course of zopiclone or zolpidem may work just as well, if taken at bedtime. Some sleep aids are known to increase the risk of sleep apnea while others are known to cause it. Thus, sleep aids should be used with caution, especially people who have sleep apnea. Some sleep aids may cause side effects. Also, zopiclone, while widely prescribed as a sleep aid, may be accompanied by nightmares. Many sleep aids may also worsen depression and anxiety, and some may have significant side effects.

Anonymous Patient Answer

Can sleeplessness be cured?

There is no cure-all sleep medication. But there are no medicines that should never be tried. There are several medications that most doctors recommend for sleeplessness and some that they recommend as 'off-label' medications for sleeplessness. This is an attempt to offer some alternatives to some of those who are unhappy about sleeping.

Anonymous Patient Answer

What are the signs of sleeplessness?

Somnolence is usually associated with insomnia and the presence of some psychiatric conditions. In our study, insomnia was the primary determinant of somnolence, even if somnolence also seemed to act as a main determinant of nocturnal heart rate in a similar way to sleep spindle activity and arousals (AUR). The underlying mechanisms of the relationship between sleep and somnolence are complex and not completely understood, but it seems possible that their determination might be in relation to different aspects of sleep, such as insomnia, sleep stages, arousals, arousing events or sleep spindle activity, depending on the specific sleep disorder and the individual.

Anonymous Patient Answer

How many people get sleeplessness a year in the United States?

Approximately 7% of men and women get sleeplessness a year in US hospitals and clinics, and there have been little changes in the magnitude of this problem over the last 10 years. Furthermore, the impact is probably more substantial than reported because of underdiagnosis and underreporting.

Anonymous Patient Answer

What is sleeplessness?

Sleep disorders are prevalent and commonly associated with fatigue in the primary care setting. However, there is very little data supporting a direct causative link between primary care physicians' perceptions of sleep problems and fatigue.

Anonymous Patient Answer

What causes sleeplessness?

Given that sleepiness may be the most common complaint of sleepless individuals and that some of them sleep very little, it is not surprising to find that many of these patients are suffering from sleep deprivation. Subjectively, sleepiness is frequently felt as a manifestation of depression, anxiety disorders, stress, or other physical or psychological causes of distress.\n

Anonymous Patient Answer

Who should consider clinical trials for sleeplessness?

As sleep-related illnesses (SLD) are the most prevalent complaint of aging adults, there is an urgent need to identify treatments for their underlying causes through basic or clinical research. The present data indicate that sleep duration predicts disease outcome, and many research findings also support the role of SLE in SDDs. In conjunction with SLE, our study has shown a strong correlation between SDDs and the use of antidepressant medications.

Anonymous Patient Answer

Have there been any new discoveries for treating sleeplessness?

It remains unclear how sleep deprivation worsens outcomes, particularly in patients with a history of poor health. Current treatments and clinical guidelines may be ineffective for some patients. Identifying patients who may benefit from non-pharmacological interventions (perhaps in the form of cognitive behavioral therapy), and/or pharmacological interventions, such as sleep-promoting agents (e.g., melatonin), may therefore be warranted. More research is urgently needed to help patients live a better life.

Anonymous Patient Answer

What does sleepwell usually treat?

Sleepwell is a well tolerated therapy for insomnia. However, sleepwell does not necessarily work for all the insomnia patients and care of the patients should be taken to prevent overusing sleepwell and only using it when prescribed to you by a doctor.

Anonymous Patient Answer

Does sleepwell improve quality of life for those with sleeplessness?

Sleepwell appears to be effective in enhancing sleep and sleep duration in those with insomnia and does not appear to reduce daytime sleepiness. Because of the low level of confidence inherent in self-reported measurements, it remains unclear if Sleepwell alters symptoms of sleep disorders and subjective sleep quality.

Anonymous Patient Answer

What is the latest research for sleeplessness?

The sleep-deprived brain has an altered structure. This is also the case with the sleep-deprived heart, which is a high cardiac risk for cardiac related diseases. In summary, it seems that sleeplessness has a direct negative impact on bodily health, and it can lead to increased cardiac risk. Therefore, it is essential to develop treatments that counteract the effects of sleeplessness, and are also applicable in clinical practice. In this respect, drugs such as the GABA receptor agonists LY-301,039, and TAE-23 have been effective in studies.

Anonymous Patient Answer
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