Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01048242
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : May 3, 2017
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):
University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Insomnia
Obstructive Sleep Apnea
Interventions: Drug: rozerem
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Ramelteon Ramelteon 8 mg oral before bedtime
Sugar Pill No text entered.

Participant Flow:   Overall Study
    Ramelteon   Sugar Pill
STARTED   12   15 
COMPLETED   8   13 
See study flow chart                4                2 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Ramelteon Ramelteon 8 mg oral before bedtime
Sugar Pill No text entered.
Total Total of all reporting groups

Baseline Measures
   Ramelteon   Sugar Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   15   27 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      12 100.0%      15 100.0%      27 100.0% 
[Units: Years]
Mean (Standard Deviation)
 73.6  (5.6)   70.6  (3.5)   72  (5.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      3  25.0%      5  33.3%      8  29.6% 
Male      9  75.0%      10  66.7%      19  70.4% 
Region of Enrollment 
[Units: Participants]
United States   12   15   27 

  Outcome Measures

1.  Primary:   Sleep Onset Latency   [ Time Frame: 4 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Auto-Continuous Positive Airway Pressure units used. Single-night of polysomnography Unequal sized arms despite randomization Low rate of completion of at-home sleep diaries Small sample size (pilot study)

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Nalaka Gooneratne
Organization: University of Pennsylvania
phone: 215 349 5938

Responsible Party: University of Pennsylvania Identifier: NCT01048242     History of Changes
Other Study ID Numbers: 804640
First Submitted: April 15, 2009
First Posted: January 13, 2010
Results First Submitted: March 22, 2017
Results First Posted: May 3, 2017
Last Update Posted: June 1, 2017