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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01048242
• Collaborator: Takeda (Industry)
• Enrollment: 27
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study objective is to determine if subject compliance with CPAP treatment of their sleep apnea is improved in subjects taking Ramelteon (their compliance may be improved because they would have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo arm.

Condition or Disease	Intervention/Treatment	Phase
Insomnia; Obstructive Sleep Apnea	Drug: rozerem; Drug: Placebo	Phase 3

Detailed Description

Randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms.

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treatment of Insomnia in Elderly Sleep Apnea Patients With Ramelteon (TAK 375)
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ramelteon Ramelteon 8 mg oral before bedtime	Drug: rozerem; Ramelteon (rozerem) 8mg oral before bedtime; Other Names: Ramelteon
Placebo Comparator: sugar pill	Drug: Placebo; placebo

Outcome Measures

Primary Outcome Measures

1. Sleep Onset Latency [4 weeks]

   Time to sleep onset as determined by polysomnography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Obstructive sleep apnea

• Insomnia

• Age>60

Exclusion Criteria:

• Cognitive impairment

• Active alcohol or substance abuse

• Active use of other sedative-hypnotic agents

• Active use of fluvoxamine (drug interaction with Ramelteon

• Evidence of hepatic dysfunction (Ramelteon contraindicated) on liver function panel

• Presence of Periodic Limb Movement Disorder or Restless Legs Syndrome

• Severe Chronic Obstructive Pulmonary Disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• Takeda

Investigators

• Principal Investigator: Nalaka Gooneratne, MD, MSc, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01048242
• Other Study ID Numbers: 804640
• First Posted: Jan 13, 2010
• Last Update Posted: Jun 1, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Arm/Group Title	Ramelteon	Sugar Pill
Arm/Group Description	Ramelteon 8 mg oral before bedtime
Period Title: Overall Study
STARTED	12	15
COMPLETED	8	13
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Ramelteon	Sugar Pill	Total
Arm/Group Description	Ramelteon 8 mg oral before bedtime	Total of all reporting groups
Overall Participants	12	15	27
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	12 100%	15 100%	27 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.6 (5.6)	70.6 (3.5)	72 (5.6)
Sex: Female, Male (Count of Participants)
Female	3 25%	5 33.3%	8 29.6%
Male	9 75%	10 66.7%	19 70.4%
Region of Enrollment (participants) [Number]
United States	12 100%	15 100%	27 100%

Outcome Measures

1. Primary Outcome

Title	Sleep Onset Latency
Description	Time to sleep onset as determined by polysomnography
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

analysis per protocol

Arm/Group Title	Ramelteon	Sugar Pill
Arm/Group Description	Ramelteon 8 mg oral before bedtime
Measure Participants	8	13
Mean (Standard Deviation) [minutes]	9.7 (10.3)	34.4 (30.7)

Adverse Events

Arm/Group Title	Ramelteon		Sugar Pill
Arm/Group Description	Ramelteon 8 mg oral before bedtime
All Cause Mortality
	Ramelteon		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ramelteon		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Ramelteon		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/8 (50%)		2/13 (15.4%)
Gastrointestinal disorders
Diarrhea	1/8 (12.5%)	1	0/13 (0%)	0
Abdominal pain	0/8 (0%)	0	1/13 (7.7%)	1
Nausea	0/8 (0%)	0	1/13 (7.7%)	1
Musculoskeletal and connective tissue disorders
Fracture	1/8 (12.5%)	1	0/13 (0%)	0
Respiratory, thoracic and mediastinal disorders
Paranasal sinusitis	1/8 (12.5%)	1	0/13 (0%)	0
Skin and subcutaneous tissue disorders
Skin ulcer	1/8 (12.5%)	1	0/13 (0%)	0

Limitations/Caveats

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.