The Psychoneuroimmunology of Insomnia

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT00680771
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 28
• Location: 1
• Duration (Months): 28
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Chronic insomnia affects approximately 8-9% of the population. The prevalence of this disorder rises dramatically across the lifespan, especially so in women. When it is chronic, insomnia is associated with increased fatigue, cognitive impairment, mood disturbance, physical complaints, diminished quality of life and increased health care consumption. There is also more limited evidence (based on epidemiologic studies or experimental studies in healthy subjects) that insomnia and/or sleep loss may be a risk factor for hypertension and/or cardiovascular disease and increased mortality.

Despite its prevalence and consequences, the pathophysiology of insomnia and, specifically, the pathway by which morbidity risk is conferred, has been relatively unstudied. With respect to medical illness in particular, insomnia may confer risk in several ways, including: 1) an inherent compromise in the restorative/conservative function of sleep, 2) the deleterious effects of "hyperarousal" and/or HPA axis abnormalities on end organ integrity and function, and/or 3) diminished immunocompetence. This study focuses on the last of these possibilities, the relationship between immune function and sleep.

The study compares immune response to a vaccine challenge in two groups: good sleepers and patients with chronic insomnia. The primary study hypothesis is that the insomnia group will have a decreased rate of adaptive immune response to the vaccine challenge than that of the good sleeper group.

Condition or Disease	Intervention/Treatment	Phase
Primary Insomnia

Study Design

• Study Type: Observational
• Actual Enrollment: 28 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Psychoneuroimmunology of Insomnia: Response to a Vaccine Challenge
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
1 Primary Insomnia
2 Good Sleepers

Outcome Measures

Primary Outcome Measures

1. Positive Antibody Response [3 Months after initial vaccination]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Their sleep schedule will include a typical bedtime of between 9:00 p.m. and 12:00 a.m. to minimize circadian rhythm influences on the diagnoses of Primary Insomnia (PI).

PIs will also meet the sleep disturbance criteria of the Pittsburgh Sleep Quality Index(PSQI) > 5 and the Insomnia Severity Index (ISI)> 15 and one of the following minimal characteristics both at intake and as an average profile from the two weeks of baseline diaries: > 30 min. sleep-onset latency (SL), > 30 min. of wake after sleep-onset (WASO), Early Morning Awakening >30 min. prior to the desired wake up time, or any two of the above complaints (Mixed Insomnia); Total Sleep Time (TST) < 6 hours [unless the Sleep Efficiency is < 80%] and the problem frequency must be > 3 nights/week; problem duration > 6 months.

Good Sleeper participants will report that they obtain enough sleep and that their sleep is restorative with average SL and WASO < 15 minutes, TST > 6 hours ESS < 5 on the ESS, < 5 on the PSQI, and < 7 on the ISI.

Exclusion Criteria for All Subjects

• any conditions contraindicated by the vaccine manufacturer or any history of allergic reactions to vaccines

• Undergoing and/or taking immunosuppressive therapies

• Sero-positive for Hep B antibodies

• Inadequate language comprehension

• Menopause, peri-menopause or premenstrual syndrome

• Pregnancy

• Unstable medical or psychiatric illness

• History of head injury with a sustained loss of consciousness

• Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence

• Use of medications thought to alter sleep such as stimulants, sedating antidepressants, and hypnotics

• Symptoms suggestive of sleep disorders other than Insomnia

• Polysomnographic data indicating sleep disorders other than Insomnia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Sleep Research Laboratory	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Wilfred R Pigeon, Ph.D., University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• ((Click here to see if you qualify for a study))

Publications

None provided.

• Responsible Party: Wilfred Pigeon, Assistant Professor of Psychiatry, University of Rochester
• ClinicalTrials.gov Identifier: NCT00680771
• Other Study ID Numbers: RSRB # 19132; 1K23NR010408
• First Posted: May 20, 2008
• Last Update Posted: Oct 17, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by Wilfred Pigeon, Assistant Professor of Psychiatry, University of Rochester: Primary Insomnia; Insomnia; Good Sleepers; Hep B; Vaccine
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Primary Insomnia	Good Sleepers
Arm/Group Description	Subjects meeting criteria for primary insomnia.	Subjects meeting criteira for Good Sleepers
Period Title: Overall Study
STARTED	15	13
COMPLETED	9	11
NOT COMPLETED	6	2

Baseline Characteristics

Arm/Group Title	Primary Insomnia	Good Sleepers	Total
Arm/Group Description	patients meeting criteria for primary insomnia.	participants meetoing criteira for Good Sleepers	Total of all reporting groups
Overall Participants	15	13	28
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	13 100%	28 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	15 100%	13 100%	28 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Positive Antibody Response
Description	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.
Time Frame	3 Months after initial vaccination

Outcome Measure Data

Analysis Population Description

From subjects with complete data only.

Arm/Group Title	Primary Insomnia	Good Sleepers
Arm/Group Description	patients meeting criteria for primary insomnia.	participants meetoing criteira for Good Sleepers
Measure Participants	8	11
Number [participants]	7 46.7%	7 53.8%

Adverse Events

Arm/Group Title	Primary Insomnia		Good Sleepers
Arm/Group Description	patients meeting criteria for primary insomnia.		participants meetoing criteira for Good Sleepers
All Cause Mortality
	Primary Insomnia		Good Sleepers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Primary Insomnia		Good Sleepers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Primary Insomnia		Good Sleepers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/13 (0%)

Limitations/Caveats

Sample size limited by much higher than expected number of otherwise eligible participants having alrady been exposed to Hep B vaccine or virus.

More Information

Certain Agreements

All Principal Investigators ARE 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.