Table 4.
Clinical studies evaluating QOS and/or daytime functioning and/or QOL in patients with comorbid insomnia (studies in which the insomnia effects could not be distinguished from those associated with the primary condition)
| Study reference | Patient population | Baseline insomnia diagnosis/assessment | Assessment scales used | QOS and QOL baseline measures and other outcomes |
|---|---|---|---|---|
| 64 | Long-term hemodialysis (n = 700) | PSQI, ESS | PSQI | Two-thirds of this cohort had a PSQI score >5; gender had no impact on PSQI score |
| 65 | Hepatitis C virus, decompensated liver disease, and interferon α2b plus ribavirin (n = 53) | No formal baseline assessment | SQP | Mean SQP score of 4.7; 66% of patients reported ≥3 symptoms of disturbed sleep |
| 66 | Chronic pain (n = 60) | DSM-II/DSM-IV | PSQI global score | Sleep quality was 13.6–14.2 |
| 67 | Chronic pain (n = 51) | DSM-IV | PSQI global score | Sleep quality was rated as 13.8 |
| 69 | Psychiatrically ill patients (n = 48) | Diagnostic criteria not reported | Self-reported sleep quality (5-point scale; 0 = no problem to 4 = very much a problem) | Sleep quality rated as 2.5 |
| 69 | Breast cancer survivors (n = 14) | Trouble sleeping on 28/7 nights, poor daytime functioning affecting physical well-being, emotions, ability to concentrate, ability to carry out usual activities or cope with stress | Sleep diary (5-point scale; 5 = good sleep) | Sleep quality rated as 2.9 |
| 43 | Breast cancer survivors (n = 72) | DSM-IV, ICD-10 | FACT-B | Global assessment ranged from 108.5 to 109 |
| 31 | Fibromyalgia (n = 42) | Structured interview criteria for insomnia and ≥1 h of nocturnal wake time over 1 week of sleep log monitoring | MOS SF-36 | Mental health composite score ranged from 46.1 to 51.3 |
| 35 | Good sleepers (n = 1867), level I insomnia (n = 464), level II insomnia (n = 1116) | HSQ and MOS SF-36 Sleep-loss category items (level I = difficulty attaining or maintaining sleep, level II = level I with daytime dysfunction) | HSQ MOS SF-36 | Level II insomnia associated with significantly lower scores in all domains versus noninsomnia. Scores for level I insomnia were lower but not significant Level II but not level I insomnia associated with more physician and ER visits, calls to physician, and OTC medications versus noninsomnia Both level I and II insomnia associated with more laboratory tests and drug prescriptions than noninsomnia |
| 70 | Major depressive disorder (n = 12) | PSQI | PSQI global score | Sleep quality rated as 15 (range 9–19) |
| 41 | Cancer patients with depression (n = 42) | C-LSEQ | C-LSEQ (5-point Likert scale; lower score = better sleep) EuroQoL-5D (lower score = better QOL) | Mean QOS rated as 4.3 QOL: Mobility 2.0; self-care 1.8; pain/discomfort 2.1 |
| 29 | Lung cancer outpatients (n = 29) | No formal baseline assessment of insomnia | MOS SF-36 PSQI, ESS, night-time wrist actigraphy |
Patients with lung cancer had a negative correlation between the mental and physical (P = 0.004) components of the SF-36 and sleep time Patients with lung cancer had a worse QOS (PSQI: 9.6 versus 5.6; P < 0.001), lower sleep efficiency (P = 0.002), higher sleep fragmentation (P = 0.002), and greater excessive daytime sleepiness (ESS: 8.6 versus 5.6; P = 0.0) than age-matched noncancer patients with treated sleep apnea |
| 71 | Major depressive disorder (n = 332) | PSQI | PSQI global score | Sleep quality was rated as 12.0–12.5 |
| 72 | Assisted living geriatric residents, 58–104 years (n = 188) | Effect of sleep (insomnia and daytime sleepiness) on cognitive and physical function | SQ (QOS) MMSE, NPI, CSDD (psychiatric and neurological status) PGDRS (physical daily living function) GMHRS (general medical health) | Subjects with insomnia had similar use of most antidepressants but higher use of hypnotics and sedatives than those without insomnia Subjects with and without impaired daytime function had similar use of all medications Subjects with insomnia only had better cognitive and physical function than those without insomnia (no insomnia or daytime dysfunction or daytime dysfunction only) Subjects with daytime dysfunction only had worse cognitive and physical function than those without daytime dysfunction (no insomnia or daytime dysfunction or insomnia only) |
| 73 | Patients with depression (n = 16) | Insomnia-related items on the Hamilton Depression Rating Scale with a total score of ≥3 | Self-reported subjective estimates of sleep quality | Mean subjective sleep quality rated as 1.8 |
| 12 | Anxiety disorders (n = 22) | Sleep eligibility criteria not reported | PSQI global score | Mean sleep quality was rated as 5 (range 2–10) |
Abbreviations: QOS, quality of sleep; QOL, quality of life; PSQI, Pittsburgh Sleep Quality Index; ESS, Epworth Sleepiness Scale; SQP, Sleep Quality Profile; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; ICD, International Classification of Diseases; FACT-B, Functional Assessment of Cancer Therapy-Breast; MOS SF-36, Medical Outcomes Study 36-item Short-Form; HSQ, Health Status Questionnaire; SQ, Sleep Questionnaire; C-LSEQ, Chonnam National University Hospital-Leeds Sleep Evaluation Questionnaire; MMSE, Mini-Mental State Examination; NPI, Neuropsychiatric Inventory; CSDD, Cornell Scale for Depression in Dementia; PGDRS, Psychogeriatric Dependency Rating Scale – Physical subscale; GMHRS, General Medical Health Rating Scale.