| Trial ID: | L4001 |
| Source ID: | NCT03818581
|
| Associated Drug: |
Suvorexant
|
| Title: |
Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03818581/results
|
| Conditions: |
Type 2 Diabetes Mellitus|Insomnia|Sleep Disorder|Inflammation
|
| Interventions: |
DRUG: Suvorexant|OTHER: Placebo
|
| Outcome Measures: |
Primary: Subjective Total Sleep Time, Total sleep time as reported on daily sleep diaries, 2 weeks | Secondary: Subjective Wake After Sleep Onset, Total time awake after sleep onset as reported on daily sleep diaries, 2 weeks|Insomnia Severity Index, A validated tool to measure insomnia severity, on a scale of 0-28, with a higher score representing greater insomnia severity., 2 weeks
|
| Sponsor/Collaborators: |
Sponsor: Massachusetts General Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
108
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-03-15
|
| Completion Date: |
2021-11-03
|
| Results First Posted: |
2023-03-02
|
| Last Update Posted: |
2024-08-20
|
| Locations: |
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03818581
|
