InsomniaPhase 2NCT05908526
Insomnia Treatment and EMA (Ecological Momentary Assessment) Outcomes
A Phase 2 study testing Baseline surveys, Cognitive testing and EMAs and Actiwatch in people with Insomnia, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The goal of this study is to examine the impact of suvorexant, an FDA-approved insomnia medication, on daytime symptoms (as measured by the Daytime Insomnia Symptoms Scale: cognition, positive mood, negative mood, and fatigue/sleepiness) among older adults with insomnia. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Baseline surveys, Cognitive testing and EMAs and Actiwatch
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2023to 8 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets Diagnostic and Statistical Manual - Fifth Edition (DSM-5) diagnostic criteria for insomnia disorder.
- Insomnia Severity Index total score >10.
- Insomnia symptoms must include problems with wake after sleep onset.
- Insomnia symptom duration > 6 months.
- Baseline self-reported total sleep time < 6.5 hours per night.
Who cannot join
- High risk for untreated organic sleep disorders other than insomnia (narcolepsy, periodic limb movement disorder, etc) as determined by structured clinical interview and investigator clinical judgment.
- Current diagnosis of a major untreated psychiatric disorder(s).
- History of serious suicide attempt within past 5 years.
- History of alcohol or substance abuse (including prescription medication abuse) within past 5 years.
- Heavy alcohol consumption (e.g., >5 drinks per day or > 14 drinks per week.
- Heavy caffeine use [(>2 cups of coffee/day (equivalent).
Show all 10Show fewer
- Current tobacco or nicotine use.
- History of previous allergic reaction, sensitivity, or severe side effects to sedative hypnotics.
- CYP3A inhibitors.
- Refusal to discontinue or intention to initiate OTC or other sleep aids during study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: The Impact of Suvorexant on Cognitive Function and Daytime Symptoms Among Community-dwelling Older Adults With Insomnia: A Placebo-controlled, Randomized Clinical Trial Using Remote Monitoring and Ecological Momentary Assessment
The goal of this study is to examine the impact of suvorexant, an FDA-approved insomnia medication, on daytime symptoms (as measured by the Daytime Insomnia Symptoms Scale: cognition, positive mood, negative mood, and fatigue/sleepiness) among older adults with insomnia. The primary hypothesis is that relative to placebo, suvorexant will improve sleep and daytime symptoms. The word "placebo" refers to a harmless pill with no therapeutic effect.
Read the detailed description
The study will take about six to eight weeks to complete. Participants will have a home sleep apnea test (HSAT) and complete a clinical interview. Participants will also complete a baseline assessment, which will take place over one or two days (about 3 hours total).
During the study, participants will complete research questionnaires and cognitive testing at baseline and post-baseline (after treatment). Participants will also complete brief EMA surveys (sleep diary and Daytime Insomnia Symptoms Scale) via mobile device 4 times per day for approximately 16 days; each survey will take about 2 minutes or less to complete. Participants will also wear an actigraph on the non-dominant wrist. This device looks like a wristwatch and measures ambulatory movement, a validated proxy for sleep.
- Conditions
- Insomnia
- Being tested
- Baseline surveys, Cognitive testing and EMAs, Actiwatch, suvorexant (or placebo), Placebo
- 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.
Baseline surveys, Cognitive testing and EMAsBehavioural
Also called ecological momentary assessment
Outcome assessments are conducted at two weeks while participants are on study treatment or placebo and include self-report questionnaires and cognitive testing administered by computer.
ActiwatchDevice
Also called actigraphy
Participants will wear an actiwatch for 16 days while completing EMA surveys. It has a small sensor that tracks motion.
suvorexant (or placebo)Drug
Also called Belsomra
FDA approved which is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
PlaceboOther
Also called no drug
An inactive substance that looks like the drug or treatment being tested.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants will start on 10mg suvorexant, po, qhs, including instructions on dosage, expectations, and potential side effects, for two nights. Following this low-dose run-in period, individuals in the treatment condition will be increased to 20mg for a 14-day active treatment period (i.e.,16 nights taking a pill). Other assessments include self-report research questionnaires and cognitive testing (completed at baseline and post-treatment), as well as EMA surveys, daily sleep diaries, and actigraphy. Receives: Behavioral: Baseline surveys, Cognitive testing and EMAs; Device: Actiwatch; Drug: suvorexant (or placebo) |
| Placebo | Placebo comparator | Participants in the control condition will take placebo (no drug) pill form, po, qhs, including instructions on dosage, expectations, and potential side effects for (16 nights taking a pill). Other assessments include self-report research questionnaires and cognitive testing, daily sleep diaries, and actigraphy. Receives: Behavioral: Baseline surveys, Cognitive testing and EMAs; Device: Actiwatch; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Daytime Insomnia Symptoms Scale (DISS)
This measure assesses daytime symptoms and functional impairments in five domains: alert cognition, fatigue, sleepiness, negative mood, and positive mood. Participants will complete this survey four times per day on their smart phone for approximately 16 days. The possible score range is 0-100, with higher scores indicating greater levels of a given construct.
Measured: Baseline (start of study) and end of study (before day 16).
Change in Insomnia Severity as Assessed by Insomnia Severity Index
The Insomnia Severity Index is a brief self-report instrument that measures subjective symptoms and consequences of insomnia as well as the degree of distress caused by those difficulties. Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: Baseline (start of study) and end of study (before day 16).
Secondary outcomes (9)
Change in Sleepiness as Assessed by Epworth Sleepiness Scale
The Epworth Sleepiness Scale is a brief self-report instrument that measures daytime sleepiness. Total scores range from 0 to 24, with higher scores indicating greater severity of sleepiness.
Measured: Baseline (start of study) and end of study (before day 16).
Change in Depression as Assessed by Patient Health Questionnaire-9
The Patient Health Questionnaire-9 is a brief self-report instrument that measures depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms.
Measured: Baseline (start of study) and end of study (before day 16).
Change in Anxiety as Assessed by Generalized Anxiety Disorder-7
The Generalized Anxiety Disorder-7 is a brief self-report instrument that measures anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater levels of depressive symptoms.
Measured: Baseline (start of study) and end of study (before day 16).
Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Lapses
PVT is a computer-based, chronometric test to measure reactions to specified small changes in a changing environment. Response time is scored in seconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
Measured: Baseline (start of study) and end of study (before day 16).
Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Median Reaction Time
PVT is a computer-based, chronometric test to measure reactions to specified small changes in a changing environment. Response time is scored in seconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
Measured: Baseline (start of study) and end of study (before day 16).
Change in Cognitive Performance Assessed by the Stroop Test: Accuracy
Stroop test is a computer-based test of colors and words to measure cognitive interference. Response time is scored in seconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
Measured: Baseline (start of study) and end of study (before day 16).
Change in Cognitive Performance Assessed by the Stroop Test: Response Time in Milliseconds
Stroop test is a computer-based test of colors and words to measure cognitive interference. Response time is scored in milliseconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
Measured: Baseline (start of study) and end of study (before day 16).
Change in Cognitive Performance Assessed by the Task-switching: Response Time in Milliseconds
Task-switching is a computer-based, chronometric test to measure response time and response accuracy. Response time is scored in milliseconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
Measured: Baseline (start of study) and end of study (before day 16).
Change in Cognitive Performance Assessed by the Task-switching
Task-switching is a computer-based, chronometric test to measure response time and response accuracy. Response time is scored in seconds. Response accuracy is scored numerically, with lower numbers indicating better response accuracy.
Measured: Baseline (start of study) and end of study (before day 16).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start9 Oct 2023
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study employs a two-group (suvorexant, 20mg, qhs, versus placebo) parallel design and involves a baseline assessment, 2-day low-dose run-in, and approximately 14-day active treatment phase with intensive ambulatory monitoring via wrist actigraphy and ecological momentary assessment (EMA). Outcome assessments are conducted at two weeks while participants are on study treatment or placebo and include self-report questionnaires and objective cognitive testing administered by computer.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Emerson Wickwire, University of Maryland, Baltimore
- Investigators
- Emerson M Wickwire, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908526
- Sponsor's protocol ID
- HP-00100622
- Status last verified
- Sep 2025
- First submitted
- 11 May 2023
- Last updated
- 30 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to make individual participant data (IPD) available to other researchers at this time.
Publications
Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
PubMed 18509902Buysse DJ, Thompson W, Scott J, Franzen PL, Germain A, Hall M, Moul DE, Nofzinger EA, Kupfer DJ. Daytime symptoms in primary insomnia: a prospective analysis using ecological momentary assessment. Sleep Med. 2007 Apr;8(3):198-208. doi: 10.1016/j.sleep.2006.10.006. Epub 2007 Mar 23.
PubMed 17368098Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Suvorexant in Elderly Patients with Insomnia: Pooled Analyses of Data from Phase III Randomized Controlled Clinical Trials. Am J Geriatr Psychiatry. 2017 Jul;25(7):791-802. doi: 10.1016/j.jagp.2017.03.004. Epub 2017 Mar 8.
PubMed 28427826Wickwire EM, Verceles AC, Chen S, Zhao Z, Rogers VE, Wilckens KA, Buysse DJ. Smart Phone/Ecological Momentary Assessment of Sleep and Daytime Symptoms Among Older Adults With Insomnia. Am J Geriatr Psychiatry. 2023 May;31(5):372-378. doi: 10.1016/j.jagp.2023.01.020. Epub 2023 Feb 1.
PubMed 36813640Wickwire EM, Zhou J, Chen S, Wilckens KA, Steenbergh TA, Buysse DJ, Verceles AC. Smartphone-Based Real-Time Assessment of Daytime Insomnia Symptoms With Suvorexant: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2550186. doi: 10.1001/jamanetworkopen.2025.50186.
PubMed 41490112
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Suvorexant on Cognitive Function and Daytime Symptoms Among Community-dwelling Older Adults With Insomnia: A Placebo-controlled, Randomized Clinical Trial Using Remote Monitoring and Ecological Momentary Assessment
- ClinicalTrials.gov ID
- NCT05908526
- Acronym / sponsor ID
- HP-00100622
- Conditions
- Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Posted 30 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to examine the impact of suvorexant, an FDA-approved insomnia medication, on daytime symptoms (as measured by the Daytime Insomnia Symptoms Scale: cognition, positive mood, negative mood, and fatigue/sleepiness) among older adults with insomnia. The primary hypothesis is that relative to placebo, suvorexant will improve sleep and daytime symptoms. The word "placebo" refers to a harmless pill with no therapeutic effect.
Detailed description
The study will take about six to eight weeks to complete. Participants will have a home sleep apnea test (HSAT) and complete a clinical interview. Participants will also complete a baseline assessment, which will take place over one or two days (about 3 hours total).
During the study, participants will complete research questionnaires and cognitive testing at baseline and post-baseline (after treatment). Participants will also complete brief EMA surveys (sleep diary and Daytime Insomnia Symptoms Scale) via mobile device 4 times per day for approximately 16 days; each survey will take about 2 minutes or less to complete. Participants will also wear an actigraph on the non-dominant wrist. This device looks like a wristwatch and measures ambulatory movement, a validated proxy for sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study employs a two-group (suvorexant, 20mg, qhs, versus placebo) parallel design and involves a baseline assessment, 2-day low-dose run-in, and approximately 14-day active treatment phase with intensive ambulatory monitoring via wrist actigraphy and ecological momentary assessment (EMA). Outcome assessments are conducted at two weeks while participants are on study treatment or placebo and include self-report questionnaires and objective cognitive testing administered by computer.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Baseline surveys, Cognitive testing and EMAs, Device: Actiwatch, Drug: suvorexant (or placebo)Participants will start on 10mg suvorexant, po, qhs, including instructions on dosage, expectations, and potential side effects, for two nights. Following this low-dose run-in period, individuals in the treatment condition will be increased to 20mg for a 14-day active treatment period (i.e.,16 nights taking a pill). Other assessments include self-report research questionnaires and cognitive testing (completed at baseline and post-treatment), as well as EMA surveys, daily sleep diaries, and actigraphy. |
| Placebo | Placebo comparator | Behavioral: Baseline surveys, Cognitive testing and EMAs, Device: Actiwatch, Other: PlaceboParticipants in the control condition will take placebo (no drug) pill form, po, qhs, including instructions on dosage, expectations, and potential side effects for (16 nights taking a pill). Other assessments include self-report research questionnaires and cognitive testing, daily sleep diaries, and actigraphy. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets Diagnostic and Statistical Manual - Fifth Edition (DSM-5) diagnostic criteria for insomnia disorder.
- Insomnia Severity Index total score >10.
- Insomnia symptoms must include problems with wake after sleep onset.
- Insomnia symptom duration > 6 months.
- Baseline self-reported total sleep time < 6.5 hours per night.
Key exclusion criteria (10 listed)
- High risk for untreated organic sleep disorders other than insomnia (narcolepsy, periodic limb movement disorder, etc) as determined by structured clinical interview and investigator clinical judgment.
- Current diagnosis of a major untreated psychiatric disorder(s).
- History of serious suicide attempt within past 5 years.
- History of alcohol or substance abuse (including prescription medication abuse) within past 5 years.
- Heavy alcohol consumption (e.g., >5 drinks per day or > 14 drinks per week.
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 |
|---|---|---|
| Baseline surveys, Cognitive testing and EMAsAlso: ecological momentary assessmentOutcome assessments are conducted at two weeks while participants are on study treatment or placebo and include self-report questionnaires and cognitive testing administered by computer. | Behavioural | Placebo, Treatment |
| ActiwatchAlso: actigraphyParticipants will wear an actiwatch for 16 days while completing EMA surveys. It has a small sensor that tracks motion. | Device | Placebo, Treatment |
| suvorexant (or placebo)Also: BelsomraFDA approved which is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. | Drug | Treatment |
| PlaceboAlso: no drugAn inactive substance that looks like the drug or treatment being tested. | Other | Placebo |
Primary outcome
Change in Daytime Insomnia Symptoms Scale (DISS)
Time frame: Baseline (start of study) and end of study (before day 16).
This measure assesses daytime symptoms and functional impairments in five domains: alert cognition, fatigue, sleepiness, negative mood, and positive mood. Participants will complete this survey four times per day on their smart phone for approximately 16 days. The possible score range is 0-100, with higher scores indicating greater levels of a given construct.
Change in Insomnia Severity as Assessed by Insomnia Severity Index
Time frame: Baseline (start of study) and end of study (before day 16).
The Insomnia Severity Index is a brief self-report instrument that measures subjective symptoms and consequences of insomnia as well as the degree of distress caused by those difficulties. Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.
9 secondary outcomes
Change in Sleepiness as Assessed by Epworth Sleepiness Scale
Time frame: Baseline (start of study) and end of study (before day 16).
Change in Depression as Assessed by Patient Health Questionnaire-9
Time frame: Baseline (start of study) and end of study (before day 16).
Change in Anxiety as Assessed by Generalized Anxiety Disorder-7
Time frame: Baseline (start of study) and end of study (before day 16).
Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Lapses
Time frame: Baseline (start of study) and end of study (before day 16).
Change in Cognitive Performance Assessed by the PVT (Psychomotor Vigilance Test): Median Reaction Time
Time frame: Baseline (start of study) and end of study (before day 16).
Change in Cognitive Performance Assessed by the Stroop Test: Accuracy
Time frame: Baseline (start of study) and end of study (before day 16).
Change in Cognitive Performance Assessed by the Stroop Test: Response Time in Milliseconds
Time frame: Baseline (start of study) and end of study (before day 16).
Change in Cognitive Performance Assessed by the Task-switching: Response Time in Milliseconds
Time frame: Baseline (start of study) and end of study (before day 16).
Change in Cognitive Performance Assessed by the Task-switching
Time frame: Baseline (start of study) and end of study (before day 16).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18509902Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
- Background: PubMed 17368098Buysse DJ, Thompson W, Scott J, Franzen PL, Germain A, Hall M, Moul DE, Nofzinger EA, Kupfer DJ. Daytime symptoms in primary insomnia: a prospective analysis using ecological momentary assessment. Sleep Med. 2007 Apr;8(3):198-208. doi: 10.1016/j.sleep.2006.10.006. Epub 2007 Mar 23.
- Background: PubMed 28427826Herring WJ, Connor KM, Snyder E, Snavely DB, Zhang Y, Hutzelmann J, Matzura-Wolfe D, Benca RM, Krystal AD, Walsh JK, Lines C, Roth T, Michelson D. Suvorexant in Elderly Patients with Insomnia: Pooled Analyses of Data from Phase III Randomized Controlled Clinical Trials. Am J Geriatr Psychiatry. 2017 Jul;25(7):791-802. doi: 10.1016/j.jagp.2017.03.004. Epub 2017 Mar 8.
- Background: PubMed 36813640Wickwire EM, Verceles AC, Chen S, Zhao Z, Rogers VE, Wilckens KA, Buysse DJ. Smart Phone/Ecological Momentary Assessment of Sleep and Daytime Symptoms Among Older Adults With Insomnia. Am J Geriatr Psychiatry. 2023 May;31(5):372-378. doi: 10.1016/j.jagp.2023.01.020. Epub 2023 Feb 1.
- Derived from this study: PubMed 41490112Wickwire EM, Zhou J, Chen S, Wilckens KA, Steenbergh TA, Buysse DJ, Verceles AC. Smartphone-Based Real-Time Assessment of Daytime Insomnia Symptoms With Suvorexant: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2550186. doi: 10.1001/jamanetworkopen.2025.50186.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available to other researchers at this time.
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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.
Emerson M Wickwire, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baseline surveys, Cognitive testing and EMAs and Actiwatch in people with Insomnia, run by University of Maryland, Baltimore 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 30 Oct 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Daytime Insomnia Symptoms Scale (DISS) (time frame: Baseline (start of study) and end of study (before day 16).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05908526, which also lists 5 linked publications.
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 30 Oct 2025.