InsomniaMBAT-2NCT03187340
Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults-2
A study testing Sleep education and relaxation 1 and Sleep education and relaxation 2 in people with Insomnia, run by Nalaka Gooneratne at 1 site in United States.
Trial summary
Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Sleep education and relaxation 1 and Sleep education and relaxation 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: 1) Sleep onset latency > 30 min for at least 3 nights per week
Exclusion Criteria: 1) Unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in English (the study questionnaires are in English and do not exist in validated form for other languages). 2) Cognitive impairment; cognitively impaired patients may not be able to comply with the protocol). 3) History of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder 4) Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19103
About this study
Official title: Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Randomized Study
Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia
- Conditions
- Insomnia
- Being tested
- Sleep education and relaxation 1, Sleep education and relaxation 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.
Sleep education and relaxation 1Behavioural
Sleep hygiene and relaxation training; Sleep education and relaxation 1
Sleep education and relaxation 2Behavioural
Modified sleep hygiene and relaxation training; Sleep education and relaxation 2
| Study group | Role | What they receive |
|---|---|---|
| Sleep education and relaxation 1 | Active comparator | Behavioral education intervention about sleep and relaxation Receives: Behavioral: Sleep education and relaxation 1 |
| Sleep education and relaxation 2 | Experimental | Behavioral education intervention about sleep and relaxation Receives: Behavioral: Sleep education and relaxation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep onset latency
time to fall asleep
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start20 Jun 2019
- Primary completion31 May 2022
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nalaka Gooneratne
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Medical Electronics
- Responsible party
- Sponsor-investigator, Nalaka Gooneratne, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187340
- Sponsor's protocol ID
- 10053582
- Acronym
- MBAT-2
- Status last verified
- Feb 2024
- First submitted
- 12 Jun 2017
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At conclusion of study as per NIH guidelines
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Randomized Study
- ClinicalTrials.gov ID
- NCT03187340
- Acronym / sponsor ID
- MBAT-2 / 10053582
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Nalaka GooneratneUniversity, hospital or other
- Collaborators
- Advanced Medical Electronics
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jun 2017 (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.
Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep education and relaxation 1 | Active comparator | Behavioral: Sleep education and relaxation 1Behavioral education intervention about sleep and relaxation |
| Sleep education and relaxation 2 | Experimental | Behavioral: Sleep education and relaxation 2Behavioral education intervention about sleep and relaxation |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Sleep education and relaxation 1Sleep hygiene and relaxation training; Sleep education and relaxation 1 | Behavioural | Sleep education and relaxation 1 |
| Sleep education and relaxation 2Modified sleep hygiene and relaxation training; Sleep education and relaxation 2 | Behavioural | Sleep education and relaxation 2 |
Primary outcome
Sleep onset latency
Time frame: four weeks
time to fall asleep
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Yes. At conclusion of study as per NIH guidelines
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep education and relaxation 1 and Sleep education and relaxation 2 in people with Insomnia, run by Nalaka Gooneratne 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?
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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. 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?
Results are not available in the source record.
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 onset latency (time frame: four weeks). 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 8 Feb 2024.