Trial Outcomes & Findings for The Psychoneuroimmunology of Insomnia (NCT NCT00680771)

Results Overview

Sero-Response to the Hepatitis B vaccine, defined as reaching or exceeding a Hepatitis B surface antigen level of greater than or equal to 10mIU/mL.

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

3 Months after initial vaccination

Results posted on

2012-10-17

Participant Flow

Pre-menopausal women aged 25-50 with either Primary Insomnia (PI) or Good Sleep (GS) were recruited from posters, flyers, and newspaper advertisements in the Rochester, NY region during the period of 2008-2010.

There were two study groups, but this did not involve random assignment. Group assignment to either Primary Insomnia or Good Sleeper was based on subjective (sleep diaries and validated instruments)and objective (polysomnography) measures of sleep. Twenty-eight subjects were enrolled.

Participant milestones

Participant milestones
Measure	Primary Insomnia Subjects meeting criteria for primary insomnia.	Good Sleepers Subjects meeting criteira for Good Sleepers
Overall Study STARTED	15	13
Overall Study COMPLETED	9	11
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Primary Insomnia Subjects meeting criteria for primary insomnia.	Good Sleepers Subjects meeting criteira for Good Sleepers
Overall Study Withdrawal by Subject	1	0
Overall Study Sleep Apnea suspected after PSG	1	0
Overall Study Prior Exposure to Hepatitus B Vaccine	4	2

Baseline Characteristics

The Psychoneuroimmunology of Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Insomnia n=15 Participants patients meeting criteria for primary insomnia.	Good Sleepers n=13 Participants participants meetoing criteira for Good Sleepers	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Months after initial vaccination

Population: From subjects with complete data only.

Sero-Response to the Hepatitis B vaccine, defined as reaching or exceeding a Hepatitis B surface antigen level of greater than or equal to 10mIU/mL.

Outcome measures

Outcome measures
Measure	Primary Insomnia n=8 Participants patients meeting criteria for primary insomnia.	Good Sleepers n=11 Participants participants meetoing criteira for Good Sleepers
Positive Antibody Response	7 participants	7 participants

Adverse Events

Primary Insomnia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Good Sleepers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wilfred Pigeon

University of rochester

Phone: (585) 275-3374

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place