Trial · NCT01300455
Effects of Suvorexant in Participants With Obstructive Sleep Apnea (MK-4305-036)
NCT01300455, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2014-08-29
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Effects of Suvorexant in Participants With Obstructive Sleep Apnea (MK-4305-036). Trials, record NCT01300455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01300455
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Suvorexant in Participants With Obstructive Sleep Apnea (MK-4305-036)
- NCT number
- NCT01300455
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Sleep Apnea
- Interventions
- Suvorexant, Matching Placebo
- First posted
- 2011-02-21
- Last updated
- 2018-09-21
- Results first posted
- 2014-08-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Apnea-Hypopnea Index (AHI) | Day 4 | Evaluation of the effect of multiple dose administration of suvorexant on AHI as measured by polysomnography. The AHI is an overall index of obstructive sleep apnea (OSA) severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to \<15/hr and moderate OSA = 15 to \<30/hr. |
| Primary | Number of Participants With an Adverse Event | Up to 14 days after last dose | An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product. |
| Primary | Number of Participants Who Discontinued Study Drug Due to an AE | Up to 13 days | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product. |
| Secondary | Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time | Day 1 and Day 4 | Evaluation of the effect of multidose dose suvorexant on mean SaO2 during total sleep time as measured by pulse oximetry. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode. |
| Secondary | Percentage of Total Sleep Time That Arterial SaO2 is Less Than 90%, 85%, and 80% | Day 1 and Day 4 | Evaluation of the percentage of the night in which SaO2 is less than 90%, less than 85% and less than 80% following multiple dose administration of suvorexant and placebo. Total sleep time is the total of all REM and non-REM sleep in a sleep episode. |
| Secondary | Mean Arterial SaO2 for Different Sleep Stages | Day 1 and Day 4 | Comparison of the mean SaO2 during different sleep stages (REM, Non-REM, and awake) following multiple dose administration of suvorexant and placebo. Sleep stages were determined by polysomnography. |
| Secondary | Mean AHI | Day 1 | Evaluation of the effect of multiple dose administration of suvorexant on AHI as measured by polysomnography. The AHI is an overall index of OSA severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to \<15/hr and moderate OSA = 15 to \<30/hr. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Apnea-Hypopnea Index (AHI) | Day 4 | Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo. | Events per hour | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants With an Adverse Event | Up to 14 days after last dose | All participants were included in the Safety Population. | participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinued Study Drug Due to an AE | Up to 13 days | All participants were included in the Safety Population. | participants | NUMBER |
| SECONDARY | Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time | Day 1 and Day 4 | Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo. | Percentage of Oxygen Saturation | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Total Sleep Time That Arterial SaO2 is Less Than 90%, 85%, and 80% | Day 1 and Day 4 | Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo. | Percentage of Total Sleep Time | MEAN |
| SECONDARY | Mean Arterial SaO2 for Different Sleep Stages | Day 1 and Day 4 | Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo. | Percentage of Oxygen Saturation | LEAST_SQUARES_MEAN |
| SECONDARY | Mean AHI | Day 1 | Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. | Events per hour | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Apnea-Hypopnea Index (AHI) | Suvorexant (40 mg) | 17.07 | 95% Confidence Interval 13.30 to 20.84 | Events per hour | |
| Mean Apnea-Hypopnea Index (AHI) | Placebo | 14.41 | 95% Confidence Interval 10.61 to 18.22 | Events per hour | |
| Number of Participants With an Adverse Event | Suvorexant (40 mg) | 8 | participants | ||
| Number of Participants With an Adverse Event | Placebo | 4 | participants | ||
| Number of Participants Who Discontinued Study Drug Due to an AE | Suvorexant (40 mg) | 0 | participants | ||
| Number of Participants Who Discontinued Study Drug Due to an AE | Placebo | 0 | participants | ||
| Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time | Suvorexant (40 mg) | Day 1 (n = 26, 24) | 94.12 | 95% Confidence Interval 93.48 to 94.75 | Percentage of Oxygen Saturation |
| Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time | Placebo | Day 1 (n = 26, 24) | 94.15 | 95% Confidence Interval 93.50 to 94.80 | Percentage of Oxygen Saturation |
| Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time | Suvorexant (40 mg) | Day 4 (n = 26, 25) | 94.15 | 95% Confidence Interval 93.53 to 94.78 | Percentage of Oxygen Saturation |
| Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time | Placebo | Day 4 (n = 26, 25) | 94.21 | 95% Confidence Interval 93.59 to 94.84 | Percentage of Oxygen Saturation |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Suvorexant (40 mg) Then Placebo | 13 | |
| Period 1 | STARTED | Placebo Then Suvorexant (40 mg) | 13 | |
| Period 1 | COMPLETED | Suvorexant (40 mg) Then Placebo | 13 | |
| Period 1 | COMPLETED | Placebo Then Suvorexant (40 mg) | 13 | |
| Period 1 | NOT COMPLETED | Suvorexant (40 mg) Then Placebo | 0 | |
| Period 1 | NOT COMPLETED | Placebo Then Suvorexant (40 mg) | 0 | |
| Washout | STARTED | Suvorexant (40 mg) Then Placebo | 13 | |
| Washout | STARTED | Placebo Then Suvorexant (40 mg) | 13 | |
| Washout | COMPLETED | Suvorexant (40 mg) Then Placebo | 12 | |
| Washout | COMPLETED | Placebo Then Suvorexant (40 mg) | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Suvorexant (40 mg) | 0 | 26 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 26 | |
| other | Somnolence | Nervous system disorders | Suvorexant (40 mg) | 5 | 26 | |
| other | Somnolence | Nervous system disorders | Placebo | 0 | 26 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Suvorexant (40 mg) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Suvorexant (40 mg) | 5 | 26 |
| Total, other adverse events | Placebo | 2 | 26 |
| Total, serious adverse events | Suvorexant (40 mg) | 0 | 26 |
| Total, serious adverse events | Placebo | 0 | 26 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26194728 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Suvorexant (40 mg) vs Placebo: Number of Participants With an Adverse Event | Trial comparisons |
| Suvorexant (40 mg) vs Placebo: Number of Participants Who Discontinued Study Drug Due to an AE | Trial comparisons |
| Suvorexant (40 mg) vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01300455
GET https://conductscience.org/api/trials/v1/NCT01300455/results?page=2