Insomnia Behavioral Intervention Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: Behavioral approach 1, Comparator: Behavioral approach 2.
- Who it may be relevant to
- Registry conditions: Chronic Insomnia. Basic parameters: 55 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Behavioral Intervention to Reduce Sedative Use in Older Adults With Chronic Insomnia
Overview
This randomized pilot study (n=20) explores the effects of a behavioral intervention, that includes sleep hygiene improvements, in long-term users of sleeping pills, aiming to alleviate or stabilize symptoms of insomnia, monitor and decrease sleeping pill usage. Adherence will be monitored by an optional smartphone application.
Detailed description
This randomized pilot study has a goal of enrolling 20 study participants. The investigators will examine the effects of a behavioral intervention, that includes sleep hygiene improvements such as regular sleep schedules, with assisted coaching support from the research team. Study participants are long-term users of sleeping pills. The goal is to improve or stabilizie insomnia symptoms and decrease sleeping pill usage. Study participant adherence will be monitored by an optional smartphone application.
Interventions
- Behavioral Experimental: Behavioral approach 1
Includes changing sleep habits and cognitions around sleep from a mental level - Behavioral Comparator: Behavioral approach 2
Includes changing sleep habits and awarenes of sleep from a perception level
Primary outcome measures
- Sleep Pill Dosage [Time frame: 28-day follow-up]
Secondary outcome measures (1)
- Sleep Efficiency [Time frame: 28-day follow-up]
Eligibility criteria
Inclusion criteria
- Age of 55-85
- Use of sleeping pill medication for sleep at least 3 nights a week
- Diagnosed with Chronic Insomnia by a physician
- Speaks English above a 6th-grade level
- Has access to a smartphone and/or smart tablet and can use it
- Has regular access to internet
Exclusion criteria
- Presence of major depression or other severe psychopathology (e.g., bipolar disorder, psychosis, alcohol/substance abuse, etc.)
- Presence of an acute or severe medical condition which, in the opinion of the research team, would interfere with the study participant's ability to participate in the research study, such as an acute heart attack, recent severe trauma, etc.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Pennsylvania School of Medicine — Philadelphia
Identifiers
NCT: NCT05301543 · 849022