CLINICAL TRIAL

Treatment for Sleeplessness

Waitlist Available · 18+ · All Sexes · Palo Alto, CA

This study is evaluating whether a digital application may help treat insomnia for veterans with co-morbid psychopathology.

See full description

About the trial for Sleeplessness

Eligible Conditions
Insomnia · Sleep Initiation and Maintenance Disorders

Treatment Groups

This trial involves a single treatment. Treatment 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.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
at least 18 years of age (no upper age limit)
meet DSM-5 defined criteria for insomnia disorder
be on a stable dose of any prescription medication (including sleep medication) for at least 2 weeks prior to the in-person screening assessment
have comorbid psychopathology (i.e., symptoms of Posttraumatic Stress Disorder (PTSD), anxiety, and/or depression)
View All
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: 12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up)
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 weeks (end of Intervention Phase) and 16 weeks (Follow-Up).
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 Treatment will improve 3 primary outcomes and 4 secondary outcomes in patients with Sleeplessness. Measurement will happen over the course of 0 weeks (baseline), 12 weeks (end of Intervention Phase), and 16 weeks (Follow-Up).

Changes in The Patient Health Questionnaire: Depression Scale (PHQ-9)
0 WEEKS (BASELINE), 12 WEEKS (END OF INTERVENTION PHASE), AND 16 WEEKS (FOLLOW-UP)
The PHQ-9 is a 9-item self-report scale assessing depression over the last two weeks (Kroenke et al., 2002). An additional item asking about global depression and interference with life activities is not included in the PHQ-9 score. Items are scored from 0 (not at all) to 3 (nearly every day), for a total score range of 0 to 27.
0 WEEKS (BASELINE), 12 WEEKS (END OF INTERVENTION PHASE), AND 16 WEEKS (FOLLOW-UP)
Changes in The Posttraumatic Checklist-5 (PCL-5)
0 WEEKS (BASELINE), 12 WEEKS (END OF INTERVENTION PHASE), AND 16 WEEKS (FOLLOW-UP)
The PCL-5 is a self-report measure of PTSD symptom severity (Weathers et al., 2013). The PCL is a 20-item measure which asks respondents how much they had been bothered in the prior month by their most traumatic experience. Item responses range from 0 (not very much) to 4 (extremely) with a total score range is 0-80. DSM-5 symptom cluster scores sum item scores: Cluster B (items 1-5), C (6-7), D (8-14), and E (items 15-20).
0 WEEKS (BASELINE), 12 WEEKS (END OF INTERVENTION PHASE), AND 16 WEEKS (FOLLOW-UP)
Changes in the Insomnia Severity Index (ISI)
0 WEEKS (BASELINE), 12 WEEKS (END OF INTERVENTION PHASE), AND 16 WEEKS (FOLLOW-UP)
The ISI is used to assess self-reported insomnia severity (Bastien et al., 2001). It is a 7-item self-report scale assessing sleep problem severity over the last two weeks, rated on a 5-point scale from 0 to 4; a higher score indicates higher severity. The ISI sums scores on the 7 items (1a, 1b, 1c, 2, 3, 4, 5) for a total score range of 0 to 28.
0 WEEKS (BASELINE), 12 WEEKS (END OF INTERVENTION PHASE), AND 16 WEEKS (FOLLOW-UP)
Changes in The Brief Inventory for Psychosocial Functioning (B-IPF)
0 WEEKS (BASELINE), 12 WEEKS (END OF INTERVENTION PHASE), AND 16 WEEKS (FOLLOW-UP)
The B-IPF-7 is a 7-item measure scored from 0 (not at all) to 6 (very much) (Bovin et al., 2018). The total score is the mean of the sum of all 7 items. The B-IPF assesses social functioning, academic and occupational functioning, daily activities over the past 30 days.
0 WEEKS (BASELINE), 12 WEEKS (END OF INTERVENTION PHASE), AND 16 WEEKS (FOLLOW-UP)
Changes in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
0 WEEKS (BASELINE), 12 WEEKS (END OF INTERVENTION PHASE), AND 16 WEEKS (FOLLOW-UP)
The GAD-7 is a 7-item anxiety scale (Spitzer et al., 2006) assessing symptoms over the past two weeks. Item scores range from 0 (not at all) to 3 (nearly every day). Items are summed to yield a total score.
0 WEEKS (BASELINE), 12 WEEKS (END OF INTERVENTION PHASE), AND 16 WEEKS (FOLLOW-UP)
Changes in Consensus Sleep Diary (CSD)
12 WEEKS (END OF INTERVENTION PHASE) AND 16 WEEKS (FOLLOW-UP)
The CSD (Carney et al., 2012) will be used to monitor self-reported sleep during the baseline phase, over the course of the digitally administered CBT-I intervention, and throughout follow-up. The CSD is a standardized sleep diary based on expert consensus and qualitative patient input.
12 WEEKS (END OF INTERVENTION PHASE) AND 16 WEEKS (FOLLOW-UP)
See More

Who is running the study

Principal Investigator
S. M.
Shannon McCaslin, Clinical Psychologist
Palo Alto Veterans Institute for Research

Patient Q & A Section

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

What is the average age someone gets sleeplessness?

The majority of sleep complaints reported during the sleep study ranged in [age range] 20–39 years. The prevalence of chronic sleep complaints at age 49 years was similar to the prevalence previously reported in age 30–39 years.

Anonymous Patient Answer

What is sleeplessness?

Sleep deprivation is a common phenomenon that impacts the daily lives of many people and a key predisposing factor for psychological issues including depression. While there has been increased research into sleep deprivation, there is a paucity of recent, good-quality controlled data on sleep restriction. The study presented herein has a number of methodological advantages that should make this question a high priority for rigorous consideration.

Anonymous Patient Answer

Can sleeplessness be cured?

Recent findings, the sleep deprivation group showed higher sleep intensity and lower sleep complaints than the non-deprivation group. Sleep deprivation, at least when a continuous form, can be a valuable treatment tool in the adjustment of insomnia symptoms.

Anonymous Patient Answer

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

About 4 billion adults have one or more hours of sleeplessness each night in the United States, which represents about 10% of total sleep time.

Anonymous Patient Answer

What are common treatments for sleeplessness?

The majority of patients with insomnia complain of excessive daytime sleepiness (EDS). Mild EDS appears not to be as harmful to social productivity or occupational productivity as the extreme forms of sleeplessness such as daytime hypersomnia. Therefore, the treatment of insomnia should not only aim to reduce sleepiness but also improve social and occupational functioning.

Anonymous Patient Answer

What causes sleeplessness?

More than half of women reported sleeplessness with an average sleep duration of just 7.5 hr per night, and no differences in perceived insomnia prevalence when comparing women who were daytime napping for <3 h per day.

Anonymous Patient Answer

What are the signs of sleeplessness?

Signs of sleeplessness are common and include irritability, sleepiness, difficulty falling asleep. Sleep deprivation may induce other mood and behavior symptoms, often affecting mood, behavior, and interpersonal relationships. Patients who do not have sleep disorders can benefit from treatment of sleep disorders. Patients should be aware of these symptoms before the patient is seen by the physician. Once symptoms are identified, diagnosis of sleep disorders should be pursued.

Anonymous Patient Answer

How serious can sleeplessness be?

There is significant evidence that more than 70% of adults report sleeplessness at some point in their lives. It is evident that the issue of sleeplessness is important to some people because it can influence their functioning and can lead to depressive symptoms. The issue of sleeplessness is not only important to clinical evaluations but also to our everyday lives; as a result some sleep researchers are using new techniques and approaches to understand and manage sleeplessness. Some effective approaches can be found on the website http://smartsleep.org/slowlovers/topics.html. If you have some questions to ask about sleeplessness, visit the Smart Sleep website directly.

Anonymous Patient Answer

What is treatment?

Most people with sleep disorders have other medical problems associated with them. It may be helpful to find sleep treatment for all these conditions before treatment of the secondary medical condition for sleep disorders is considered.

Anonymous Patient Answer

Have there been any new discoveries for treating sleeplessness?

Only caffeine did not have a beneficial effect for narcolepsy patients. A higher dosages of topiramate, modafinil and armodafinil significantly improves EDS. A moderate dosage of benzodiazepines may improve EDS but should only be taken as an option in case of treatment resistant. The lack of effectiveness and questionable safety of modafinil and armodafinil in narcolepsy is the basis for the development of other agents for narcolepsy.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

Many of the ongoing clinical trials have been reviewed by the FDA. It is difficult to predict the outcome of the clinical trials, but the results are reported only for some of the clinical trials. The findings from a thorough review and analysis of the current clinical trials suggest that there may be no benefit to the addition of a short-acting β-agonist to standard first-line therapy.

Anonymous Patient Answer

What is the primary cause of sleeplessness?

The primary cause of sleeplessness in this population was stress. In a group of adults that are not afflicted with multiple medical problems, there was scant evidence of the presence of sleep disorders other than insomnia. This may be a reflection of the fact that participants with sleep disorders were not evaluated using validated sleep-detection measures.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Sleeplessness by sharing your contact details with the study coordinator.