Chronic InsomniaIBINCT05301543
Insomnia Behavioral Intervention Study
A study testing Experimental: Behavioral approach 1 and Comparator: Behavioral approach 2 in people with Chronic Insomnia, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Experimental: Behavioral approach 1 and Comparator: Behavioral approach 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 20 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
Nalaka S Gooneratne, 215-662-7772, ngoonera@pennmedicine.upenn.edu
Nalaka Gooneratne, MD, MSc.
About this study
Official title: Behavioral Intervention to Reduce Sedative Use in Older Adults With Chronic Insomnia
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.
Read the 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.
- Conditions
- Chronic Insomnia
- Being tested
- Experimental: Behavioral approach 1, Comparator: Behavioral approach 2
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Behavioral approach 1Behavioural
Includes changing sleep habits and cognitions around sleep from a mental level
Comparator: Behavioral approach 2Behavioural
Includes changing sleep habits and awarenes of sleep from a perception level
| Study group | Role | What they receive |
|---|---|---|
| Behavioral approach 1 | Experimental | This includes sleep hygiene and other elements to serve as an experimental arm; subjects will receive a clinically proven therapeutic intervention. Receives: Behavioral: Experimental: Behavioral approach 1 |
| Behavioral approach 2 | Active comparator | This includes sleep hygiene and other elements to serve as an active comparator; subjects will receive a clinically proven therapeutic intervention. Receives: Behavioral: Comparator: Behavioral approach 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Pill Dosage
We will monitor changes in participants' sleep pill total dosage taken over one week using the sleep diary (which includes a daily question regarding sleeping pills used that night). The usage reduction will be calculated as a percent (total weekly usage at end of study divided by total weekly usage during the baseline week).
Measured: 28-day follow-up
Secondary outcomes (1)
Sleep Efficiency
Sleep efficiency which will be calculated using information from the sleep diary (logged daily from day 0 until day 28).
Measured: 28-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start10 Jan 2022
- Primary completion8 Apr 2028 (estimated)
- Study completion20 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nalaka Gooneratne, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301543
- Sponsor's protocol ID
- 849022
- Acronym
- IBI
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Intervention to Reduce Sedative Use in Older Adults With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT05301543
- Acronym / sponsor ID
- IBI / 849022
- Conditions
- Chronic Insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 8 Apr 2028 (estimated)
- Study completion
- 20 May 2029 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral approach 1 | Experimental | Behavioral: Experimental: Behavioral approach 1This includes sleep hygiene and other elements to serve as an experimental arm; subjects will receive a clinically proven therapeutic intervention. |
| Behavioral approach 2 | Active comparator | Behavioral: Comparator: Behavioral approach 2This includes sleep hygiene and other elements to serve as an active comparator; subjects will receive a clinically proven therapeutic intervention. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Experimental: Behavioral approach 1Includes changing sleep habits and cognitions around sleep from a mental level | Behavioural | Behavioral approach 1 |
| Comparator: Behavioral approach 2Includes changing sleep habits and awarenes of sleep from a perception level | Behavioural | Behavioral approach 2 |
Primary outcome
Sleep Pill Dosage
Time frame: 28-day follow-up
We will monitor changes in participants' sleep pill total dosage taken over one week using the sleep diary (which includes a daily question regarding sleeping pills used that night). The usage reduction will be calculated as a percent (total weekly usage at end of study divided by total weekly usage during the baseline week).
1 secondary outcome
Sleep Efficiency
Time frame: 28-day follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Insomnia
Not yet recruiting
Online Tai Chi Versus Digital CBT-I for Chronic Insomnia
Chronic Insomnia Disorder
Not yet recruiting
Shiwei Anshen Granules for Chronic Insomnia
Chronic Insomnia
Active, not recruiting
Impact of Insomnia Treatment on Brain Responses During Resting-state and Cognitive Tasks
Chronic Insomnia
Active, not recruiting
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
Chronic Insomnia, Cancer-related Problem/Condition
RecruitingPhase 2
Deep Sleep in Older Adults
Insomnia, Insomnia Chronic
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Behavioral approach 1 and Comparator: Behavioral approach 2 in people with Chronic Insomnia, run by University of Pennsylvania 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nalaka Gooneratne (215662 7772, ngoonera@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Pill Dosage (time frame: 28-day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.