Primary Insomnia
Conditions
Keywords
Primary Insomnia, Insomnia, Good Sleepers, Hep B, Vaccine
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.
Interventions
None listed
Sponsors
National Institute of Nursing Research (NINR)
University of Rochester
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Primary Insomnia patients meeting criteria for primary insomnia. | 15 |
| Good Sleepers participants meetoing criteira for Good Sleepers | 13 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Prior Exposure to Hepatitus B Vaccine | 4 | 2 |
| Overall Study | Sleep Apnea suspected after PSG | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Primary Insomnia | Good Sleepers | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 13 |
| serious Total, serious adverse events | 0 / 15 | 0 / 13 |
Outcome results
Primary
Positive Antibody Response
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
Population: From subjects with complete data only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Insomnia | Positive Antibody Response | 7 participants |
| Good Sleepers | Positive Antibody Response | 7 participants |